Recall archive
91 recalls · page 3 of 4
Reported Mar 28, 2018
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — 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.
FDA (openFDA device enforcement)
Reported Jan 31, 2018
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — 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
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2017
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2017
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
FDA (openFDA device enforcement)
Reported Jul 5, 2017
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The incorrect Loctite adhesive was used to assemble the impactor heads.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 17, 2017
PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product details — This lot of left plates were laser etched and packaged as right plates.
FDA (openFDA device enforcement)
Reported May 10, 2017
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The stability data does not support the product labeled with a 10-year shelf life.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2017
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
17 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2017
Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The single use devices are provided sterile and do not have an expiration date on the label.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2017
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — Lack of 510k clearance for design modification.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2017
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped…
FDA (openFDA device enforcement)
Reported Jan 11, 2017
Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 9, 2016
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Some Bipolar shells were manufactured with an out of specification retainer groove.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 28, 2016
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Sterility seal integrity failures on the Renasys Sterile Transparent Film
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — Sterility compromised due to breach in sterile packaging
FDA (openFDA device enforcement)
Reported Aug 3, 2016
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
FDA (openFDA device enforcement)
Reported Jul 27, 2016
Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The device could be subject to breaches of its sterile packaging.
FDA (openFDA device enforcement)
Reported Jul 6, 2016
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2016
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE)…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 24, 2016
High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc., Endoscopy Div.
Matched: Brand — During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing…
FDA (openFDA device enforcement)
Reported Feb 24, 2016
LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial…
FDA (openFDA device enforcement)
Reported Feb 17, 2016
Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — Blade exhibiting fracture during hip arthroscopy procedures
FDA (openFDA device enforcement)
Reported Feb 10, 2016
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc., Endoscopy Div.
Matched: Brand — Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 13, 2016
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — 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…
1 more product in this recall
FDA (openFDA device enforcement)
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