Memphis, TN, United States
Wright Medical Technology, Inc. recalls
22 recalls recorded since 2018, most recently on 18 August 2026. 11 are listed as ongoing. Status and classification are as published by the FDA.
Recalls22
Ongoing (FDA)11
Terminated or completed11
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 August 2026
- Reason
- Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.
- Distribution
- US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3334-2026
- CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Ongoing Class II Medical devices
- Recall started
- 6 March 2024
- Reason
- Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.
- Distribution
- US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1477-2024
- stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Ongoing Class II Medical devices
- Recall started
- 13 June 2023
- Reason
- 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, thereby preventing pin placement through the pin holes.
- Distribution
- There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2105-2023
- Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Ongoing Class II Medical devices
- Recall started
- 10 April 2023
- Reason
- Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1467-2023, Z-1466-2023
- stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
- stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Ongoing Class II Medical devices
- Recall started
- 2 February 2023
- Reason
- 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 comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
- Distribution
- US Nationwide distribution in the state of NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1170-2023, Z-1169-2023
- ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
- ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Terminated Class II Medical devices
- Recall started
- 30 September 2022
- Terminated
- 21 August 2026
- Reason
- The tibial tray lock detail is oversized (larger than specification).
- Distribution
- US Nationwide distribution in the state of New York.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0139-2023, Z-0140-2023
- Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
- Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Ongoing Class II Medical devices
- Recall started
- 3 August 2022
- Reason
- 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 the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0006-2023, Z-0005-2023
- stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of tw
- stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two
Ongoing Class II Medical devices
- Recall started
- 27 July 2022
- Reason
- An incorrect sizing label was applied to the carton packaging.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, NY, PA, and TN. The countries of the Australia, France, the Netherlands, Sweden, and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1567-2022
- Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Ongoing Class II Medical devices
- Recall started
- 14 June 2022
- Reason
- The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
- Distribution
- Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1366-2022
- Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Ongoing Class II Medical devices
- Recall started
- 2 June 2022
- Reason
- The instrument is incorrectly color coded.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1291-2022
- Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Terminated Class II Medical devices
- Recall started
- 10 March 2022
- Terminated
- 1 April 2026
- Reason
- The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
- Distribution
- US distribution to Florida, North Carolina, Ohio, and Texas
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0853-2022
- EasyFuse Dynamic Compression System Instrument Pack
Terminated Class II Medical devices
- Recall started
- 15 February 2022
- Terminated
- 5 October 2022
- Reason
- An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
- Distribution
- International distribution to the country of France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0786-2022
- Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
Terminated Class II Medical devices
- Recall started
- 9 February 2022
- Terminated
- 25 January 2024
- Reason
- Product was labelled with the incorrect manufacturing and distribution dates.
- Distribution
- International distribution in the countries of Japan and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0679-2022
- The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the pl
Ongoing Class II Medical devices
- Recall started
- 3 December 2021
- Reason
- The incorrect product is contained in the packaging.
- Distribution
- Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0393-2022, Z-0392-2022
- Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
- Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
Ongoing Class II Medical devices
- Recall started
- 3 December 2021
- Reason
- Incorrect product is contained in the packaging.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, IA, and SC. The countries of Australia, Canada, Chile, Spain, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0401-2022
- Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
Terminated Class II Medical devices
- Recall started
- 4 November 2021
- Terminated
- 6 January 2023
- Reason
- The package contents and package labeling do not match.
- Distribution
- US Nationwide distribution in the states of MI and PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0316-2022, Z-0315-2022
- INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
- INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Terminated Class II Medical devices
- Recall started
- 26 August 2020
- Terminated
- 27 April 2021
- Reason
- Lack of sterility assurance
- Distribution
- USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2989-2020
- EVOLVE STEM 8.5MM Model # 496S085
Terminated Class II Medical devices
- Recall started
- 28 July 2020
- Terminated
- 16 November 2022
- Reason
- Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
- Distribution
- US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2797-2020, Z-2796-2020
- Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a compl
- Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete ran
Terminated Class II Medical devices
- Recall started
- 9 April 2020
- Terminated
- 2 November 2020
- Reason
- One lot of INBONE Tibial Trays is missing the plasma coating.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1924-2020
- WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movemen
Terminated Class II Medical devices
- Recall started
- 27 December 2019
- Terminated
- 23 July 2021
- Reason
- 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 affected product.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1101-2020, Z-1102-2020
- WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
- WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
Terminated Class II Medical devices
- Recall started
- 14 March 2018
- Terminated
- 5 October 2020
- Reason
- Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
- Distribution
- US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1375-2018, Z-1376-2018
- WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
- WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
Terminated Class II Medical devices
- Recall started
- 8 November 2016
- Terminated
- 3 November 2020
- Reason
- The firm discovered a lack of adequate documentation confirming sterility on certain products.
- Distribution
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0564-2020, Z-0568-2020, Z-0570-2020, Z-0565-2020, Z-0573-2020, Z-0569-2020, Z-0572-2020, Z-0562-2020, Z-0566-2020, Z-0567-2020, Z-0563-2020, Z-0571-2020
- PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
- Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
- SWANSON FINGER JOINT #1, Part Number 4700001
- INBONE STEM, TIBIAL, TOP, Part Number 200011901
- CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
- EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
- SWANSON TRAPEZIUM IMPLANT, Part Number 4520002
- SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
- and 4 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.