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Smith & Nephew Recalls
258 recalls on record · September 26, 2012 to June 24, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 11, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals u
Hazard: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
November 9, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71
Hazard: Some Bipolar shells were manufactured with an out of specification retainer groove.
November 9, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 7132204
Hazard: Some Bipolar shells were manufactured with an out of specification retainer groove.
September 28, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film I
Hazard: Sterility seal integrity failures on the Renasys Sterile Transparent Film
September 14, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
Hazard: Sterility compromised due to breach in sterile packaging
August 3, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip compone
Hazard: The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
July 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
Hazard: The device could be subject to breaches of its sterile packaging.
July 6, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indi
Hazard: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
July 6, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indic
Hazard: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
July 6, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is in
Hazard: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
July 6, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is ind
Hazard: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
July 6, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is in
Hazard: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
July 6, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is ind
Hazard: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Ne
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Ne
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nep
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nep
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nep
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephe
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephe
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephe
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & N
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Ne
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Ne
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nep
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Neph
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephe
Hazard: 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.
April 27, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephe
Hazard: 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.
February 24, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosth
Hazard: The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.
February 17, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.
Hazard: Blade exhibiting fracture during hip arthroscopy procedures