Wright Medical Technology, Inc.

FDA Regulatory Profile

Wright Medical Technology, Inc. has 79 FDA recalls, 37 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest recall
Z-3334-2026 · Class II · Aug 18, 2026
Latest inspection
Oct 5, 2026 · NAI
Latest 510(k)
Feb 17, 2023

Newer recall under related name Howmedica Osteonics: Sep 16, 2026, Z-0167-2027.

Reviewing Wright Medical Technology, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Wright Medical Technology, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls79Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections37Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Howmedica Osteonics
Same company group
24830190Sep 16, 2026 (Z-0167-2027)
Stryker Sustainability Solutions
Same company group
723490Aug 19, 2026 (Z-3187-2026)
Sage Products
Same company group
723192Aug 18, 2026 (D-0837-2026)
Stryker
Same company group
7727170Jul 1, 2026 (Z-2833-2026)
Stryker Corporation
Same company group
11581222Jun 8, 2026 (Z-2866-2026)
Physio-Control
Same company group
4194131Apr 13, 2026 (Z-2065-2026)
Stryker Neurovascular
Same company group
10934110Apr 6, 2026 (Z-2552-2026)
Stryker Communications
Same company group
20450Feb 23, 2026 (Z-1688-2026)
Stryker Spine
Same company group
2975120Feb 28, 2025 (Z-1491-2025)
Stryker Orthopaedics
Same company group
62400Apr 15, 2024 (Z-1915-2024)
Stryker Leibinger Gmbh And Co. Kg
Same company group
25030Apr 4, 2024 (Z-1885-2024)
Stryker Instruments
Same company group
17710Jun 24, 2022 (Z-1478-2022)

Recent Recalls

NumberClassProductDate
Z-3334-2026Class IICHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating…Aug 18, 2026
Z-1477-2024Class IIstryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplastyMar 6, 2024
Z-2105-2023Class IIStryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.Jun 13, 2023
Z-1466-2023Class IIstryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixationApr 10, 2023
Z-1467-2023Class IIstryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixationApr 10, 2023
Z-1169-2023Class IIORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation deviceFeb 2, 2023
Z-1170-2023Class IIORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation deviceFeb 2, 2023
Z-0139-2023Class IIStryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903…Sep 30, 2022
Z-0140-2023Class IIStryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904…Sep 30, 2022
Z-0006-2023Class IIstryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus…Aug 3, 2022
Z-0005-2023Class IIstryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus…Aug 3, 2022
Z-1567-2022Class IIStryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.Jul 27, 2022
Z-1366-2022Class IIWright EVOLVE TRIAD Plate Cutter, REF 49510120Jun 14, 2022
Z-1291-2022Class IIStryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument…Jun 2, 2022
Z-0853-2022Class IIEasyFuse Dynamic Compression System Instrument PackMar 10, 2022
Z-0786-2022Class IIWright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a…Feb 15, 2022
Z-0679-2022Class IIThe DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of…Feb 9, 2022
Z-0393-2022Class IIStryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.Dec 3, 2021
Z-0392-2022Class IIStryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.Dec 3, 2021
Z-0401-2022Class IIWright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component…Dec 3, 2021

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 5, 2026Fort Lauderdale, FLBiologicsNo Action Indicated (NAI)3011400128
Jul 8, 2025Riverside, CABiologicsNo Action Indicated (NAI)3026266879
Sep 10, 2024Arlington, TNBiologicsNo Action Indicated (NAI)1043534
Mar 21, 2024Langhorne, PABiologicsNo Action Indicated (NAI)3009993615
Aug 9, 2023Englewood, COBiologicsNo Action Indicated (NAI)3010131759
Oct 25, 2022Norwood, MABiologicsNo Action Indicated (NAI)3009381000
Jun 15, 2022Orlando, FLBiologicsNo Action Indicated (NAI)3009378925
Apr 14, 2022Columbus, OHBiologicsNo Action Indicated (NAI)3010292857
Sep 29, 2021Arlington, TNDevicesVoluntary Action Indicated (VAI)1043534
Aug 8, 2019Arlington, TNBiologicsNo Action Indicated (NAI)1043534
Jul 2, 2019Langhorne, PABiologicsNo Action Indicated (NAI)3009993615
Jan 31, 2019Round Rock, TXBiologicsNo Action Indicated (NAI)3011007241
Dec 18, 2018Orlando, FLBiologicsNo Action Indicated (NAI)3009378925
Nov 29, 2018Salt Lake City, UTBiologicsNo Action Indicated (NAI)3010994039
Nov 26, 2018Norwood, MABiologicsNo Action Indicated (NAI)3009381000
Oct 17, 2018Englewood, COBiologicsNo Action Indicated (NAI)3010131759
Aug 1, 2018Columbus, OHBiologicsNo Action Indicated (NAI)3010292857
Apr 13, 2017Arlington, TNBiologicsNo Action Indicated (NAI)1043534
Jun 6, 2016Arlington, TNBiologicsNo Action Indicated (NAI)1043534
Mar 29, 2016Orlando, FLBiologicsNo Action Indicated (NAI)3009378925

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3011400128Fort Lauderdale, FL1Oct 5, 2026
FEI 3026266879Riverside, CA1Jul 8, 2025
FEI 1043534Arlington, TN11Sep 10, 2024
FEI 3009993615Langhorne, PA4Mar 21, 2024
FEI 3010131759Englewood, CO3Aug 9, 2023
FEI 3009381000Norwood, MA4Oct 25, 2022
FEI 3009378925Orlando, FL4Jun 15, 2022
FEI 3010292857Columbus, OH3Apr 14, 2022
FEI 3011007241Round Rock, TX2Jan 31, 2019
FEI 3010994039Salt Lake City, UT2Nov 29, 2018
FEI 3010667733Arlington, TN1May 23, 2014
FEI 3009331856San Antonio, TX1Aug 2, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K221645PROstep(TM) MIS 5mm Chamfer Screw SystemFeb 17, 2023

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.