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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.
May 30, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in
Hazard: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
May 30, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients i
Hazard: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
May 30, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients
Hazard: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
May 30, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients
Hazard: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
May 30, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Compo
Hazard: 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.
May 2, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Hazard: 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.
April 18, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD
Hazard: 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.
March 28, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision
Hazard: 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.
January 31, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application softw
Hazard: 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.
January 31, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885
Hazard: One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
January 31, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Hazard: The expiration date provided on the label is incorrect.
January 31, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM
Hazard: 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
January 31, 2018Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM
Hazard: 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
November 22, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
Hazard: A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
November 22, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product Th
Hazard: The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
September 6, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, Q
Hazard: The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
July 5, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF
Hazard: The incorrect Loctite adhesive was used to assemble the impactor heads.
July 5, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Hazard: The incorrect Loctite adhesive was used to assemble the impactor heads.
May 17, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STER
Hazard: This lot of left plates were laser etched and packaged as right plates.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.