Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119
Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1190-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338
Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1191-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6
Software Version: RayStation 6 Service Pack 1, 2 and 3
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1192-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 6.0.0.24
Software Version: RayStation 6
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1193-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 5.0.2.35 and 5.0.3.17
Software Version: RayStation 5 Service Pack 2 and 3
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1194-2025
Open, ClassifiedPosted Feb 19, 2025·Initiated Jan 16, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System
Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7
Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause: Under Investigation by firm
Recalling firm: RAYSEARCH LABORATORIES ABType: System, Planning, Radiation Therapy TreatmentDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,
Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain,
SwitzerlandENG, Taiwan, Thailand, UK.Recall #Z-1195-2025
Open, ClassifiedPosted Feb 14, 2025·Initiated Jan 10, 2025
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042
(6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061;
Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062
Reason: Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
Root cause: Device Design
Recalling firm: Spectranetics CorporationType: Scaffold, Dissection RepairDistribution: Distribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and ATRecall #Z-1070-2025
Open, ClassifiedPosted Feb 14, 2025·Initiated Feb 15, 2024
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136
used in conjunction with Warming Blankets and Mattresses.
Reason: Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: US distribution to states of: AL, TX, NVRecall #Z-1171-2025
Open, ClassifiedPosted Feb 14, 2025·Initiated Feb 15, 2024
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
Reason: Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Root cause: Device Design
Recalling firm: Augustine Temperature Management, LLCType: System, Thermal RegulatingDistribution: US distribution to states of: AL, TX, NVRecall #Z-1172-2025
Open, ClassifiedPosted Feb 14, 2025·Initiated Jan 3, 2025
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Reason: Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
Root cause: Packaging
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US: CARecall #Z-1173-2025
Open, ClassifiedPosted Feb 14, 2025·Initiated Jan 15, 2025
DeRoyal AMG Suction Connector Tubing REF:
71-2083,
71-C506,
71-C510,
71-C512,
71-C520,
Tubing is intended for fluid movement
Reason: The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.
Root cause: Device Design
Recalling firm: DeRoyal Industries IncType: Tube, Aspirating, Flexible, ConnectingDistribution: U.S.: ND, NY, VA, WV, NJ, TN, OK, TN, GA, OH, MN, AZ, WI, IL, MA, MD, MO, AR, MS, NY, MS, SC, HI, AR, UT, HI,
O.U.S.: KuwaitRecall #Z-1174-2025
Open, ClassifiedPosted Feb 14, 2025·Initiated Jan 17, 2025
3M Prevena Plus 125 Therapy Unit and System Kits
REF:
PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US
PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US
PRE3201 Prevena Plus Peel and Place 35 cm system Kit
PRE4000US Prevena Plus 125 Therapy Unit, US
PRE4001AU PREVENA PLUS SYSTEM KIT, AU
PRE4001CA PREVENA PLUS SYSTEM KIT, CA
PRE4001UK PREVENA PLUS SYSTEM KIT, UK
PRE4001US PREVENA PLUS SYSTEM KIT, US
PRE4001 PREVENA PLUS SYSTEM KIT
PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA
PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT
PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM
PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM
PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM
PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM
PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM
PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM
Reason: Due to increase in complaints related to leak alarms
Root cause: Device Design
Recalling firm: KCI USA, INC.Type: Negative Pressure Wound Therapy Device For Reduction Of Wound ComplicationsDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.Recall #Z-1175-2025
Open, ClassifiedPosted Feb 14, 2025·Initiated Jan 17, 2025
3M V.A.C. VIA Negative Pressure Wound Therapy System
REF:
VIAKIT077D01/US - V.A.C. VIA 7 Day Kit
VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack
VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
Reason: Due to increase in complaints related to leak alarms
Root cause: Device Design
Recalling firm: KCI USA, INC.Type: Negative Pressure Wound Therapy Powered Suction PumpDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.Recall #Z-1176-2025
Open, ClassifiedPosted Feb 13, 2025·Initiated Jan 15, 2025
Brand Name: Sertera Biopsy Device
Product Name: Sertera Biopsy Device
Model/Catalog Number: Sertera-14
Software Version: N/A
Product Description: Instrument, Biopsy
Component: N/A
Reason: Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Root cause: Process control
Recalling firm: Hologic, IncType: Instrument, BiopsyDistribution: Domestic: Nationwide DistributionRecall #Z-1170-2025 Open, ClassifiedPosted Feb 12, 2025·Initiated Jan 15, 2025
MOSAIQ Oncology Information System
Reason: Image offsets calculated by oncology Information System
software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Root cause: Software design
Recalling firm: Elekta, Inc.Type: Accelerator, Linear, MedicalDistribution: US: PA, AL, FL, IA UT
OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey VenezuelaRecall #Z-1162-2025
Open, ClassifiedPosted Feb 12, 2025·Initiated Jan 20, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Reason: Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
Root cause: Under Investigation by firm
Recalling firm: Microbiologics IncType: Multi-Analyte Controls UnassayedDistribution: Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.Recall #Z-1163-2025
Open, ClassifiedPosted Feb 12, 2025·Initiated Jan 20, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Reason: Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
Root cause: Under Investigation by firm
Recalling firm: Microbiologics IncType: Multi-Analyte Controls UnassayedDistribution: Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.Recall #Z-1164-2025
Open, ClassifiedPosted Feb 12, 2025·Initiated Dec 31, 2024
AcuMatch XLE
Item Number / Product Description:
140-28-27 AM EHXL 0 LNR G 28MM
140-32-27 AM EHXL 0 LNR G 32MM
140-32-28 AM EHXL 0 LNR H 32MM
140-28-29 AM EHXL 0 LNR J 28MM
140-32-29 AM EHXL 0 LNR J 32MM
140-36-29 AM EHXL 0 LNR J 36MM
140-32-30 AM EHXL 0 LNR K 32MM
140-36-30 AM EHXL 0 LNR K 36MM
140-28-25 AM EHXL 0LNR E 28MM
140-28-26 AM EHXL 0LNR F 28MM
140-28-28 AM EHXL 0LNR H 28MM
140-36-28 AM EHXL 0LNR H 36MM
140-28-30 AM EHXL 0LNR K 28MM
142-28-24 AM EHXL 15 LNR D 28MM
142-28-26 AM EHXL 15 LNR F 28MM
142-32-27 AM EHXL 15 LNR G 32MM
142-32-28 AM EHXL 15 LNR H 32MM
142-36-28 AM EHXL 15 LNR H 36MM
142-36-29 AM EHXL 15 LNR J 26MM
142-28-29 AM EHXL 15 LNR J 28MM
142-32-29 AM EHXL 15 LNR J 32MM
142-28-30 AM EHXL 15 LNR K 28MM
142-32-30 AM EHXL 15 LNR K 32MM
142-36-30 AM EHXL 15 LNR K 36MM
142-28-25 AM EHXL 15LNR E 28MM
142-28-27 AM EHXL 15LNR G 28MM
142-28-28 AM EHXL 15LNR H 28MM
144-28-28 AM EHXL EXT LNR H 28MM
144-28-29 AM EHXL EXT LNR J 28MM
144-28-25 AM EHXL EXTLNR E 28MM
144-28-26 AM EHXL EXTLNR F 28MM
144-28-27 AM EHXL EXTLNR G 28MM
144-28-30 AM EHXL EXTLNR K 28MM
148-28-26 AM EHXL LAT LNR F 28MM
148-28-27 AM EHXL LAT LNR G 28MM
148-36-28 AM EHXL LAT LNR H 36MM
148-36-29 AM EHXL LAT LNR J 36MM
148-28-30 AM EHXL LAT LNR K 28MM
148-36-30 AM EHXL LAT LNR K 36MM
148-28-25 AM EHXL LATLNR E 28MM
148-28-28 AM EHXL LATLNR H 28MM
148-28-29 AM EHXL LATLNR J 28MM
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.
Reason: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Root cause: Nonconforming Material/Component
Recalling firm: Exactech, Inc.Type: Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedDistribution: U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA
O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and SpainRecall #Z-1165-2025
Open, ClassifiedPosted Feb 12, 2025·Initiated Dec 31, 2024
Novation XLE
Item Number / Product Description:
140-22-70 NV EHXL NTL LNR G00 22MM
140-28-50 NV EHXLNTRL LNR G0 28MM
140-28-51 NV EHXLNTRL LNR G1 28MM
140-28-52 NV EHXL NTRL LNR G228MM
140-32-51 NV EHXL NTRL LNR G132MM
140-32-52 NV EHXL NTRL LNR G232MM
140-32-53 NV EHXL NTRL LNR G332MM
140-32-54 NV EHXLNTRL LNR G4 32MM
140-32-55 NV EHXLNTRL LNR G5 32MM
140-36-52 NV EHXLNTRL LNR G2 36MM
140-36-53 NV EHXL NTRL LNR G336MM
140-36-54 NV EHXLNTRL LNR G4 36MM
140-36-55 NV EHXLNTRL LNR G5 36MM
140-40-53 NV EHXLNTRL LNR G3 40MM
140-40-54 NV EHXLNTRL LNR G4 40MM
140-40-55 NV EHXLNTRL LNR G5 40MM
142-22-68 NV EHXL ALPLNR G00 22MM
142-22-70 NV EHXL LIPLNR G00 22MM
142-28-50 NV EHXL LIP LNR G0 28MM
142-28-51 NV EHXL LIP LNR G1 28MM
142-28-52 NV EHXL LIP LNR G2 28MM
142-28-60 NV EHXL ALIPLNR G0 28MM
142-28-61 NV EHXL ALIP LNR G1 28MM
142-28-62 NV EHXL ALIP LNR G2 28MM
142-32-51 NV EHXL LIP LNR G1 32MM
142-32-52 NV EHXL LIP LNR G2 32MM
142-32-53 NV EHXL LIP LNR G3 32MM
142-32-54 NV EHXL LIP LNR G4 32MM
142-32-55 NV EHXL LIP LNR G5 32MM
142-32-61 NV EHXL ALIP LNR G1 32MM
142-32-62 NV EHXL ALIP LNR G2 32MM
142-32-63 NV EHXL ALIP LNR G3 32MM
142-32-64 NV EHXL ALIP LNR G4 32MM
142-32-65 NV EHXL ALIP LNR G5 32MM
142-36-52 NV EHXL LIP LNR G2 36MM
142-36-53 NV EHXL LIP LNR G3 36MM
142-36-54 NV EHXL LIP LNR G4 36MM
142-36-55 NV EHXL LIP LNR G5 36MM
142-36-62 NV EHXL ALIP LNR G2 36MM
142-36-63 NV EHXL ALIP LNR G3 36MM
142-36-64 NV EHXL ALIP LNR G4 36MM
142-36-65 NV EHXL ALIP LNR G5 36MM
142-40-53 NV EHXL LIP LNR G3 40MM
142-40-54 NV EHXL LIP LNR G4 40MM
142-40-55 NV EHXL LIP LNR G5 40MM
142-40-63 NV EHXL ALIP LNR G3 40MM
142-40-64 NV EHXL ALIP LNR G4 40MM
142-40-65 NV EHXL ALIP LNR G5 40MM
146-22-70 NV EHXL LATLNR G00 22MM
146-28-51 NV EHXL LAT LNR G1 28MM
146-32-51 NV EHXL LAT LNR G1 32MM
146-32-52 NV EHXL LAT LNR G2 32MM
146-32-53 NV EHXL LAT LNR G3 32MM
146-32-54 NV EHXL LAT LNR G4 32MM
146-32-55 NV EHXL LAT LNR G5 32MM
146-36-52 NV EHXL LAT LNR G2 36MM
146-36-53 NV EHXL LAT LNR G3 36MM
146-36-54 NV EHXL LAT LNR G4 36MM
146-36-55 NV EHXL LAT LNR G5 36MM
146-40-53 NV EHXL LAT LNR G3 40MM
146-40-54 NV EHXL LAT LNR G4 40MM
146-40-55 NV EHXL LAT LNR G5 40MM
148-32-51 NV EHXL 10 LNR G1 32MM
148-36-52 NV EHXL 10 LNR G2 36MM
148-36-53 NV EHXL 10 LNR G3 36MM
148-36-54 NV EHXL 10 LNR G4 36MM
148-36-55 NV EHXL 10 LNR G5 36MM
148-40-53 NV EHXL 10 LNR G3 40MM
148-40-54 NV EHXL 10 LNR G4 40MM
148-40-55 NV EHXL 10 LNR G5 40MM
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.
Open, ClassifiedPosted Feb 12, 2025·Initiated Dec 31, 2024
Alteon XLE
Item Number / Product Description:
140-22-70 NV EHXL NTL LNR G00 22MM
140-28-50 NV EHXLNTRL LNR G0 28MM
140-28-51 NV EHXLNTRL LNR G1 28MM
140-28-52 NV EHXL NTRL LNR G228MM
140-32-51 NV EHXL NTRL LNR G132MM
140-32-52 NV EHXL NTRL LNR G232MM
140-32-53 NV EHXL NTRL LNR G332MM
140-32-54 NV EHXLNTRL LNR G4 32MM
140-32-55 NV EHXLNTRL LNR G5 32MM
140-36-52 NV EHXLNTRL LNR G2 36MM
140-36-53 NV EHXL NTRL LNR G336MM
140-36-54 NV EHXLNTRL LNR G4 36MM
140-36-55 NV EHXLNTRL LNR G5 36MM
140-40-53 NV EHXLNTRL LNR G3 40MM
140-40-54 NV EHXLNTRL LNR G4 40MM
140-40-55 NV EHXLNTRL LNR G5 40MM
142-22-68 NV EHXL ALPLNR G00 22MM
142-22-70 NV EHXL LIPLNR G00 22MM
142-28-50 NV EHXL LIP LNR G0 28MM
142-28-51 NV EHXL LIP LNR G1 28MM
142-28-52 NV EHXL LIP LNR G2 28MM
142-28-60 NV EHXL ALIPLNR G0 28MM
142-28-61 NV EHXL ALIP LNR G1 28MM
142-28-62 NV EHXL ALIP LNR G2 28MM
142-32-51 NV EHXL LIP LNR G1 32MM
142-32-52 NV EHXL LIP LNR G2 32MM
142-32-53 NV EHXL LIP LNR G3 32MM
142-32-54 NV EHXL LIP LNR G4 32MM
142-32-55 NV EHXL LIP LNR G5 32MM
142-32-61 NV EHXL ALIP LNR G1 32MM
142-32-62 NV EHXL ALIP LNR G2 32MM
142-32-63 NV EHXL ALIP LNR G3 32MM
142-32-64 NV EHXL ALIP LNR G4 32MM
142-32-65 NV EHXL ALIP LNR G5 32MM
142-36-52 NV EHXL LIP LNR G2 36MM
142-36-53 NV EHXL LIP LNR G3 36MM
142-36-54 NV EHXL LIP LNR G4 36MM
142-36-55 NV EHXL LIP LNR G5 36MM
142-36-62 NV EHXL ALIP LNR G2 36MM
142-36-63 NV EHXL ALIP LNR G3 36MM
142-36-64 NV EHXL ALIP LNR G4 36MM
142-36-65 NV EHXL ALIP LNR G5 36MM
142-40-53 NV EHXL LIP LNR G3 40MM
142-40-54 NV EHXL LIP LNR G4 40MM
142-40-55 NV EHXL LIP LNR G5 40MM
142-40-63 NV EHXL ALIP LNR G3 40MM
142-40-64 NV EHXL ALIP LNR G4 40MM
142-40-65 NV EHXL ALIP LNR G5 40MM
146-22-70 NV EHXL LATLNR G00 22MM
146-28-51 NV EHXL LAT LNR G1 28MM
146-32-51 NV EHXL LAT LNR G1 32MM
146-32-52 NV EHXL LAT LNR G2 32MM
146-32-53 NV EHXL LAT LNR G3 32MM
146-32-54 NV EHXL LAT LNR G4 32MM
146-32-55 NV EHXL LAT LNR G5 32MM
146-36-52 NV EHXL LAT LNR G2 36MM
146-36-53 NV EHXL LAT LNR G3 36MM
146-36-54 NV EHXL LAT LNR G4 36MM
146-36-55 NV EHXL LAT LNR G5 36MM
146-40-53 NV EHXL LAT LNR G3 40MM
146-40-54 NV EHXL LAT LNR G4 40MM
146-40-55 NV EHXL LAT LNR G5 40MM
148-32-51 NV EHXL 10 LNR G1 32MM
148-36-52 NV EHXL 10 LNR G2 36MM
148-36-53 NV EHXL 10 LNR G3 36MM
148-36-54 NV EHXL 10 LNR G4 36MM
148-36-55 NV EHXL 10 LNR G5 36MM
148-40-53 NV EHXL 10 LNR G3 40MM
148-40-54 NV EHXL 10 LNR G4 40MM
148-40-55 NV EHXL 10 LNR G5 40MM
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.