FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
- Recall number
- Z-1477-2024
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
- Status
- Open, Classified
- Initiated
- 2024-03-06
- Posted
- 2024-04-04
- Terminated
- not on file
- 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.
- Root cause
- Process change control
- Action
- Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 03/06/2024 via email. The notice explained the issue, potential risk, and requested the consignee isolate/quarantine the affected product pending return of the device. If the affected product was further distributed, please notify the applicable parties at once about this recall. This notification letter may be copied and distributed. a. If possible, inform Stryker if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers. For questions or concerns, please contact memphis.fieldaction@stryker.com.
- Quantity
- 47 units
- Distribution
- US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
- Lot, serial or model codes
- UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094
- 510(k) numbers
- ["K123954"]
- PMA numbers
- not on file
- Product code
- HSN
- Firm FEI
- 3010667733
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28