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Wright Medical Technology, Inc.
Wright Medical Technology, Inc.: 78 FDA recall reports
Every medical device recall the FDA has published for Wright Medical Technology, Inc.. The fault, and how the agency graded it.
78Reports
0Class I
16Ongoing
2024-04-10Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Z-1477-2024 · Class II · reported 2024-04-10 · Ongoing
- Why it was recalled
- 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.
- Product
- stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
- Where it went
- US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
- How much
- 47 units
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Z-2105-2023 · Class II · reported 2023-07-12 · Ongoing
- Why it was recalled
- 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.
- Product
- Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
- Where it went
- 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.
- How much
- 106 devices
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Z-1467-2023 · Class II · reported 2023-05-03 · Ongoing
- Why it was recalled
- Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
- Product
- stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
- Where it went
- US Nationwide distribution.
- How much
- 50 units
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Z-1466-2023 · Class II · reported 2023-05-03 · Ongoing
- Why it was recalled
- Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
- Product
- stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
- Where it went
- US Nationwide distribution.
- How much
- 41 units
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Z-1170-2023 · Class II · reported 2023-03-08 · Ongoing
- Why it was recalled
- 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.
- Product
- ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
- Where it went
- US Nationwide distribution in the state of NY.
- How much
- 4 units
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Z-1169-2023 · Class II · reported 2023-03-08 · Ongoing
- Why it was recalled
- 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.
- Product
- ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
- Where it went
- US Nationwide distribution in the state of NY.
- How much
- 10 units
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Z-0139-2023 · Class II · reported 2022-11-02 · Ongoing
- Why it was recalled
- The tibial tray lock detail is oversized (larger than specification).
- Product
- Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
- Where it went
- US Nationwide distribution in the state of New York.
- How much
- 1 unit
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Z-0140-2023 · Class II · reported 2022-11-02 · Ongoing
- Why it was recalled
- The tibial tray lock detail is oversized (larger than specification).
- Product
- Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
- Where it went
- US Nationwide distribution in the state of New York.
- How much
- 1 unit
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial He
Z-0006-2023 · Class II · reported 2022-10-12 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 two systems: EVOLVE Proline and EVOLVE TRIAD.
- Where it went
- US Nationwide distribution.
- How much
- 32 units
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head
Z-0005-2023 · Class II · reported 2022-10-12 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 systems: EVOLVE Proline and EVOLVE TRIAD.
- Where it went
- US Nationwide distribution.
- How much
- 16 units
Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
Z-1567-2022 · Class II · reported 2022-08-31 · Ongoing
- Why it was recalled
- An incorrect sizing label was applied to the carton packaging.
- Product
- Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
- Where it went
- 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.
- How much
- 17 devices
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Z-1366-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- 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
- Product
- Wright EVOLVE TRIAD Plate Cutter, REF 49510120
- Where it went
- Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico
- How much
- 231
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with
Z-1291-2022 · Class II · reported 2022-07-06 · Ongoing
- Why it was recalled
- The instrument is incorrectly color coded.
- Product
- Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
- Where it went
- 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.
- How much
- 35 units
EasyFuse Dynamic Compression System Instrument Pack
Z-0853-2022 · Class II · reported 2022-04-06 · Terminated
- Why it was recalled
- The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
- Product
- EasyFuse Dynamic Compression System Instrument Pack
- Where it went
- US distribution to Florida, North Carolina, Ohio, and Texas
- How much
- 176 packs
Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component
Z-0786-2022 · Class II · reported 2022-03-23 · Terminated
- Why it was recalled
- An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
- Product
- 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.
- Where it went
- International distribution to the country of France.
- How much
- 1 package
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titaniu
Z-0679-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- Product was labelled with the incorrect manufacturing and distribution dates.
- Product
- 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 plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths
- Where it went
- International distribution in the countries of Japan and the United Kingdom.
- How much
- 12 units
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Z-0393-2022 · Class II · reported 2021-12-29 · Ongoing
- Why it was recalled
- The incorrect product is contained in the packaging.
- Product
- Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
- Where it went
- 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.
- How much
- 250 units
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHAR
Z-0401-2022 · Class II · reported 2021-12-29 · Ongoing
- Why it was recalled
- Incorrect product is contained in the packaging.
- Product
- Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AZ, IA, and SC. The countries of Australia, Canada, Chile, Spain, and United Kingdom.
- How much
- 22 units
Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
Z-0392-2022 · Class II · reported 2021-12-29 · Ongoing
- Why it was recalled
- The incorrect product is contained in the packaging.
- Product
- Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
- Where it went
- 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.
- How much
- 23 units
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Z-0316-2022 · Class II · reported 2021-12-08 · Terminated
- Why it was recalled
- The package contents and package labeling do not match.
- Product
- INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
- Where it went
- US Nationwide distribution in the states of MI and PA.
- How much
- 2 units
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Z-0315-2022 · Class II · reported 2021-12-08 · Terminated
- Why it was recalled
- The package contents and package labeling do not match.
- Product
- INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
- Where it went
- US Nationwide distribution in the states of MI and PA.
- How much
- 0 (2 Quarantined)
EVOLVE STEM 8.5MM Model # 496S085
Z-2989-2020 · Class II · reported 2020-09-30 · Terminated
- Why it was recalled
- Lack of sterility assurance
- Product
- EVOLVE STEM 8.5MM Model # 496S085
- Where it went
- USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
- How much
- 16 stems
Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is
Z-2797-2020 · Class II · reported 2020-08-19 · Terminated
- Why it was recalled
- Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
- Product
- 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 complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.
- Where it went
- US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
- How much
- 9 units
Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designe
Z-2796-2020 · Class II · reported 2020-08-19 · Terminated
- Why it was recalled
- Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
- Product
- 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 range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.
- Where it went
- US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
- How much
- 66 kits
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a
Z-1924-2020 · Class II · reported 2020-05-13 · Terminated
- Why it was recalled
- One lot of INBONE Tibial Trays is missing the plasma coating.
- Product
- 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 movement in the ankle joint.
- Where it went
- US Nationwide distribution.
- How much
- 22 units
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Z-1101-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- 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.
- Product
- WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
- Where it went
- US
- How much
- 39 devices
WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
Z-1102-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- 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.
- Product
- WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
- Where it went
- US
- How much
- 48 devices
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Z-0564-2020 · Class II · reported 2019-12-04 · Terminated
- Why it was recalled
- The firm discovered a lack of adequate documentation confirming sterility on certain products.
- Product
- PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
- Where it went
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- How much
- 19 units
Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
Z-0568-2020 · Class II · reported 2019-12-04 · Terminated
- Why it was recalled
- The firm discovered a lack of adequate documentation confirming sterility on certain products.
- Product
- Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
- Where it went
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- How much
- 66 units
SWANSON FINGER JOINT #1, Part Number 4700001
Z-0570-2020 · Class II · reported 2019-12-04 · Terminated
- Why it was recalled
- The firm discovered a lack of adequate documentation confirming sterility on certain products.
- Product
- SWANSON FINGER JOINT #1, Part Number 4700001
- Where it went
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- How much
- 20 units
Showing the 30 most recent of 78. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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