Recall archive
22 recalls · page 1 of 1
Reported Apr 10, 2024
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand · Reason for recall — Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were…
FDA (openFDA device enforcement)
Reported Jul 12, 2023
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes,…
FDA (openFDA device enforcement)
Reported May 3, 2023
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand · Product · Product details — Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2023
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 2, 2022
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — The tibial tray lock detail is oversized (larger than specification).
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2022
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand · Product · Product details — The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2022
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — An incorrect sizing label was applied to the carton packaging.
FDA (openFDA device enforcement)
Reported Jul 20, 2022
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand · Product · Product details — The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam…
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — The instrument is incorrectly color coded.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
EasyFuse Dynamic Compression System Instrument Pack
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand · Product · Product details — An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
FDA (openFDA device enforcement)
Reported Mar 9, 2022
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — Product was labelled with the incorrect manufacturing and distribution dates.
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand · Product · Product details — Incorrect product is contained in the packaging.
FDA (openFDA device enforcement)
Reported Aug 19, 2020
Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand · Product · Product details — Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2020
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand · Product · Product details — Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2019
SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — The firm discovered a lack of adequate documentation confirming sterility on certain products.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 25, 2018
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand · Product · Product details — Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2015
CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 27, 2015
PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — The term DORSAL was laser etched on the incorrect side on some of the angled handles.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 29, 2015
CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative…
18 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 17, 2014
CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wright Medical Technology, Inc.
Matched: Brand — Plates manufactured from an incorrect raw material.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2014
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microport Orthopedics Inc.
Matched: Product · Product details — Difficulty removing the cup adaptor from the impaction handle during surgery
FDA (openFDA device enforcement)
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