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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 13, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 M
Hazard: The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use.
January 13, 2016Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WIT
Hazard: 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.
December 16, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers
Hazard: 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.
December 16, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers:
Hazard: 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.
September 16, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM
Hazard: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
September 16, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 M
Hazard: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
September 16, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140
Hazard: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
July 1, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Hazard: Sterility of device maybe compromised
June 17, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Product Usage: The R3 Constrain
Hazard: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
June 17, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrai
Hazard: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
June 17, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrain
Hazard: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
June 17, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrain
Hazard: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
June 17, 2015Medical DevicesFDA
Smith & Nephew, Inc. recalls R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrain
Hazard: The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
December 17, 2014Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usa
Hazard: The stem taper on this device is undersized; the gauge point is not deep enough.
December 17, 2014Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Us
Hazard: The stem taper on this device is undersized; the gauge point is not deep enough.
December 17, 2014Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usa
Hazard: The stem taper on this device is undersized; the gauge point is not deep enough.
October 15, 2014Medical DevicesFDA
Smith & Nephew, Inc. recalls RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus
Hazard: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
October 15, 2014Medical DevicesFDA
Smith & Nephew, Inc. recalls RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters
Hazard: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
October 15, 2014Medical DevicesFDA
Smith & Nephew, Inc. recalls RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters
Hazard: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
October 1, 2014Medical DevicesFDA
Smith & Nephew, Inc. recalls RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction devi
Hazard: Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
August 27, 2014Medical DevicesFDA
Smith & Nephew, Inc. recalls TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 3811
Hazard: 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.
May 28, 2014Medical DevicesFDA
Smith & Nephew Inc recalls TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125
Hazard: A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
May 28, 2014Medical DevicesFDA
Smith & Nephew Inc recalls TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree,
Hazard: A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
March 19, 2014Medical DevicesFDA
Smith & Nephew Inc. recalls Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits
Hazard: 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
March 19, 2014Medical DevicesFDA
Smith & Nephew Inc. recalls Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing
Hazard: 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
March 19, 2014Medical DevicesFDA
Smith & Nephew Inc. recalls Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft
Hazard: 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
March 19, 2014Medical DevicesFDA
Smith & Nephew Inc. recalls Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjuncti
Hazard: 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
March 19, 2014Medical DevicesFDA
Smith & Nephew Inc. recalls Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft
Hazard: 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
March 19, 2014Medical DevicesFDA
Smith & Nephew Inc. recalls Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negat
Hazard: 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
March 5, 2014Medical DevicesFDA
Smith & Nephew Inc. recalls Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Hazard: Modification of the bacterial overflow guard (filter) and related changes to product labeling.