Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2070-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2071-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2072-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2073-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2074-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2075-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2076-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Wound Dressing With Animal-Derived Material(S)Distribution: Domestic: Nationwide Distribution.Recall #Z-2077-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Wound Dressing With Animal-Derived Material(S)Distribution: Domestic: Nationwide Distribution.Recall #Z-2078-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Wound Dressing With Animal-Derived Material(S)Distribution: Domestic: Nationwide Distribution.Recall #Z-2079-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Wound Dressing With Animal-Derived Material(S)Distribution: Domestic: Nationwide Distribution.Recall #Z-2080-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Wound Dressing With Animal-Derived Material(S)Distribution: Domestic: Nationwide Distribution.Recall #Z-2081-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Wound Dressing With Animal-Derived Material(S)Distribution: Domestic: Nationwide Distribution.Recall #Z-2082-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2083-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2084-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated May 23, 2023
TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Root cause: Under Investigation by firm
Recalling firm: TEI Biosciences, Inc.Type: Mesh, SurgicalDistribution: Domestic: Nationwide Distribution.Recall #Z-2085-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2415-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2416-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2417-2023
Open, ClassifiedPosted Sep 30, 2024·Initiated Jul 13, 2023
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Root cause: Nonconforming Material/Component
Recalling firm: Carefusion 2200 IncType: Laparoscope, General & Plastic SurgeryDistribution: US and CanadaRecall #Z-2418-2023