Brand

Smith & Nephew, Inc. Recalls

176 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Smith & Nephew, Inc..

176Total Recalls
0Critical
15.9MUnits Affected
Nov 24, 2025Most Recent
All Recalls

Every Smith & Nephew, Inc. Recall

Sorted by most recent. Click any recall for full details.

176 recalls
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, rep...
Medical Devices·71 affected·Aug 24, 2020
High RiskFDA
Smith & Nephew, Inc.
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Surgical Devices·111 affected·Aug 3, 2020
High RiskFDA
Smith & Nephew, Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patien...
Medical Devices·3 affected·Jun 29, 2020
High RiskFDA
Smith & Nephew, Inc.
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to hel...
Medical Devices·12 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
SUTUREFIX ULTRA Suture, Product number 72203855
Medical Devices·868 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff re...
Surgical Devices·137 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number ...
Medical Implants·4,172 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 7133184...
Medical Implants·1,267 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 7133...
Medical Implants·1,766 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 4...
Medical Implants·1,450 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number ...
Medical Implants·58 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Medical Devices·125,196 affected·Mar 17, 2020
High RiskFDA
Smith & Nephew, Inc.
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used ...
Medical Devices·348 affected·Feb 27, 2020
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable su...
Surgical Devices·200 affected·Jan 28, 2020
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable su...
Surgical Devices·195 affected·Jan 28, 2020
High RiskFDA
Smith & Nephew, Inc.
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Medical Devices·82 affected·Dec 30, 2019
High RiskFDA
Smith & Nephew, Inc.
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 7143441...
Surgical Devices·59 affected·Dec 16, 2019
High RiskFDA
Smith & Nephew, Inc.
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap inst...
Medical Implants·1,371 affected·Nov 11, 2019
High RiskFDA
Smith & Nephew, Inc.
LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur includ...
Medical Devices·116 affected·Oct 7, 2019
High RiskFDA
Smith & Nephew, Inc.
smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
Medical Devices·9 affected·Feb 19, 2019
High RiskFDA
Smith & Nephew, Inc.
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Medical Devices·58 affected·Feb 19, 2019
High RiskFDA
Smith & Nephew, Inc.
SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Medical Devices·72 affected·Jan 7, 2019
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical i...
Surgical Devices·65 affected·Dec 10, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical i...
Surgical Devices·46 affected·Dec 10, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 7402...
Medical Devices·64,642 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 7402...
Medical Devices·42,050 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 7402121...
Medical Devices·10,792 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF...
Medical Devices·6 affected·May 11, 2018
High RiskFDA
Smith & Nephew, Inc.
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Medical Devices·2 affected·May 11, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Medical Devices·5 affected·May 4, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and rev...
Medical Devices·0 affected·Mar 30, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and re...
Medical Devices·16 affected·Mar 30, 2018
High RiskFDA
Smith & Nephew, Inc.
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T ...
Medical Devices·59 affected·Mar 7, 2018
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are ...
Medical Devices·12 affected·Jan 15, 2018
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of ...
Medical Devices·0 affected·Dec 13, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT P...
Medical Devices·2 affected·Dec 11, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Medical Devices·22 affected·Dec 11, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (1...
Medical Devices·12 affected·Nov 29, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
Medical Devices·17 affected·Oct 24, 2017
High RiskFDA
Smith & Nephew, Inc.
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Medical Devices·9 affected·Oct 23, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee S...
Medical Implants·10 affected·Sep 14, 2017
High RiskFDA
Smith & Nephew, Inc.
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Medical Implants·27 affected·Aug 1, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only ...
Medical Implants·402 affected·Jul 24, 2017
High RiskFDA
Smith & Nephew, Inc.
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Medical Devices·36 affected·May 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
Medical Devices·1,126 affected·Mar 30, 2017
High RiskFDA
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
Medical Devices·6,997 affected·Mar 30, 2017