Recall archive
91 recalls · page 2 of 4
Reported Aug 12, 2020
SUTUREFIX ULTRA Suture, Product number 72203855
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
FDA (openFDA device enforcement)
Reported Aug 5, 2020
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the…
FDA (openFDA device enforcement)
Reported Jul 29, 2020
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
FDA (openFDA device enforcement)
Reported Jun 17, 2020
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — A manufacturing error resulted in out of specification R3 Acetabular Shells
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2020
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 29, 2020
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 8, 2020
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
FDA (openFDA device enforcement)
Reported Mar 25, 2020
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
FDA (openFDA device enforcement)
Reported Feb 26, 2020
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch…
FDA (openFDA device enforcement)
Reported Feb 5, 2020
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design…
FDA (openFDA device enforcement)
Reported Dec 25, 2019
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during…
FDA (openFDA device enforcement)
Reported Nov 20, 2019
LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the…
FDA (openFDA device enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The affected products were inadvertently packaged with an incorrect screw component.
FDA (openFDA device enforcement)
Reported Apr 3, 2019
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 27, 2019
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 23, 2019
SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
FDA (openFDA device enforcement)
Reported Oct 31, 2018
Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
FDA (openFDA device enforcement)
Reported Oct 10, 2018
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 29, 2018
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
FDA (openFDA device enforcement)
Reported Jun 27, 2018
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 20, 2018
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
FDA (openFDA device enforcement)
Reported May 30, 2018
smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — 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…
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 2, 2018
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously…
FDA (openFDA device enforcement)
Reported Apr 18, 2018
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over…
FDA (openFDA device enforcement)
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