Smith and Nephew Vulcan

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Operating rooms
• Procedure rooms
• Interventional suites

Documents & Manuals

• &ESU - Service manualService Manual · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.

• RECALL

  Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

• RECALL

  Packaging contained the incorrect size of femoral head from what was displayed on the label.

• RECALL

  The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.

• RECALL

  Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

• RECALL

  Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

• RECALL

  The labels on the packages of screws were switched.

• RECALL

  The nail head may become detached during surgery.

• RECALL

  The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

• RECALL

  A manufacturing error resulted in out of specification R3 Acetabular Shells

• RECALL

  Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.

• RECALL

  There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.

• RECALL

  Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

• RECALL

  One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

• RECALL

  One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

• RECALL

  Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.

• RECALL

  A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.

• RECALL

  The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

• RECALL

  One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.

• RECALL

  The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.

• RECALL

  In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the preview images on the Strut Settings tab.

• RECALL

  Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa

• RECALL

  Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.

• RECALL

  One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

• RECALL

  A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

• RECALL

  The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

• RECALL

  The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.

• RECALL

  This lot of left plates were laser etched and packaged as right plates.

• RECALL

  Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

• RECALL

  The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

• RECALL

  Lack of 510k clearance for design modification.

• RECALL

  Sterility compromised due to breach in sterile packaging

• RECALL

  The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.

• RECALL

  The device could be subject to breaches of its sterile packaging.

• RECALL

  The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

• RECALL

  Blade exhibiting fracture during hip arthroscopy procedures

• RECALL

  One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.

• RECALL

  The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.

• RECALL

  Sterility of device is compromised due to breach in the packaging

• RECALL

  The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

• RECALL

  The stem taper on this device is undersized; the gauge point is not deep enough.

• RECALL

  There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.

• RECALL

  A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

• RECALL

  Inner spherical radius of the shell is undersized.

• RECALL

  Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

• RECALL

  One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.

• RECALL

  The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

• RECALL

  One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).

• RECALL

  75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.

• RECALL

  Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.

• RECALL

  Distal part of the anchor may break on insertion into bone during surgery

• RECALL

  Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.

• RECALL

  Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773).

• RECALL

  SPIDER2 may unlock (loss of traction) resulting in potential movement of the patient when the device is within close proximity to an RF source. Loss of traction can potentially result in the unintended repositioning of the extremity and potential for tissue or cartilage damage

• RECALL

  Shaft tip (casting) does not meet the SNE 416 specification, which could result in rusting of the Tendon Strippers

• RECALL

  Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU)

• RECALL

  Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SKIN-PREP Protective Wipes, PERI-PREP Protective Wipes, and NO-STING SKIN-PREP Protective Wipes. These products were manufactured by H&P Industries dba The Triad Group who has initiated a recall of products manufactured i

• RECALL

  During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners.

• RECALL

  On 12/14/2010, Smith & Nephew, Inc. Wound Management Division in St. Petersburg, FL recalled their RENASYS PORT product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier.

• RECALL

  Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.

• RECALL

  FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.

• RECALL

  The firm received reports of a femoral head popping out of the liner intraoperatively.

• RECALL

  Inner packaging of sterile product was not sealed. Lack of sterility assurance.

• RECALL

  Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.

• RECALL

  Endofemoral Aimer tip may separate due to failure of the soldered joint

• RECALL

  Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side

• RECALL

  Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and December 13, 2007 and distributed by Smith&Nephew between July 18, 2007 and January 14, 2010. Affected products codes are 66800187, 66800322, 66800323, 66800324, and 66800325 with Serial Numbers startin

• RECALL

  Firm received complaints of Inclination Set Screws fracturing.

• RECALL

  Problems with transducer may result in a reduced ultrasound output.

• RECALL

  Radius at the end of the taper of the femoral implant is smaller than specification. This error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. The deficiency may not be noticed by the user. Impingement and/or wear debris may lead to revision.

• RECALL

  The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct.

• RECALL

  Hinge failure: The product is cracking or breaking during use.

• RECALL

  Products were mispackaged.

• RECALL

  46 mm Femoral head was mismarked and packaged as being 45 mm

• RECALL

  Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. This may occur during shipping.

• RECALL

  Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals.

• RECALL

  Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.

• RECALL

  The carton label may not reflect the correct size of the acetabular cup.

• RECALL

  Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use.

• RECALL

  The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.

• RECALL

  Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.

• RECALL

  The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure

• RECALL

  Drill does not contain laser etched depth marks to assure proper depth of inserted device

• RECALL

  Cupped Grasper Handle marked incorrectly as Duckbill Upbiter

• RECALL

  Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.

• RECALL

  Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.

• RECALL

  Product may not meet the established stability specification before the end of labeled expiry date.

• RECALL

  Potential for non sterility as package tray does not contain aeration holes for ETO processing.