Smith & Nephew, Inc.
187 recalls on record · Latest: Dec 24, 2025
FDA Devices Moderate Oct 28, 2020
TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
FDA Devices Moderate Oct 28, 2020
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
FDA Devices Moderate Oct 28, 2020
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
FDA Devices Moderate Oct 28, 2020
OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
FDA Devices Moderate Oct 28, 2020
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
FDA Devices Moderate Oct 28, 2020
TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
FDA Devices Moderate Oct 28, 2020
RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
FDA Devices Moderate Sep 16, 2020
EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or…
FDA Devices Moderate Aug 26, 2020
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
FDA Devices Moderate Aug 19, 2020
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with oste…
FDA Devices Moderate Aug 12, 2020
SUTUREFIX ULTRA Suture, Product number 72203855
FDA Devices Moderate Aug 5, 2020
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedu…
FDA Devices Moderate Jul 29, 2020
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the s…
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 7133194…
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 7133…
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 7…
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242…
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 7133873…
FDA Devices Moderate Jun 3, 2020
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instr…
FDA Devices Moderate Jun 3, 2020
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instr…
FDA Devices Moderate Apr 29, 2020
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
FDA Devices Moderate Apr 8, 2020
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructe…
FDA Devices Moderate Feb 26, 2020
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
FDA Devices Moderate Feb 5, 2020
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION A…
FDA Devices Moderate Dec 25, 2019
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or i…
FDA Devices Moderate Nov 20, 2019
LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple …
FDA Devices Moderate Sep 18, 2019
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 designed for…
FDA Devices Moderate Apr 3, 2019
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument us…
FDA Devices Moderate Apr 3, 2019
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument us…
FDA Devices Moderate Mar 27, 2019
smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
FDA Devices Moderate Mar 27, 2019
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
FDA Devices Moderate Jan 23, 2019
SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
FDA Devices Moderate Oct 10, 2018
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 740231…
FDA Devices Moderate Oct 10, 2018
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 740211…
FDA Devices Moderate Oct 10, 2018
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218,…
FDA Devices Moderate Aug 29, 2018
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
FDA Devices Moderate Jun 27, 2018
Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (…
FDA Devices Moderate Jun 27, 2018
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
FDA Devices Moderate Jun 20, 2018
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
FDA Devices Moderate May 30, 2018
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 revision surger…
FDA Devices Moderate May 30, 2018
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 revision surge…
FDA Devices Moderate May 2, 2018
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
FDA Devices Moderate Apr 18, 2018
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 LOCKING SCRE…
FDA Devices Moderate Jan 31, 2018
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE…
FDA Devices Moderate Jan 31, 2018
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 …
FDA Devices Moderate Jan 31, 2018
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
FDA Devices Moderate Jan 31, 2018
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilater…
FDA Devices Moderate Jan 31, 2018
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R…
FDA Devices Moderate Nov 22, 2017
smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
FDA Devices Moderate Nov 22, 2017