FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
- Recall number
- Z-0140-2023
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
- Status
- Open, Classified
- Initiated
- 2022-09-30
- Posted
- 2022-10-27
- Terminated
- not on file
- Reason
- The tibial tray lock detail is oversized (larger than specification).
- Root cause
- Device Design
- Action
- Stryker notified consignees on about 09/30/2022, via letter that was hand delivered or sent via email titled, "URGENT: MEDICAL DEVICE RECALL." The letter instructed consignees to check inventory and quarantine any affected product, return the enclosed response form, arrange for the return of affected product and notify all applicable parties of the recall if product was further distributed.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of New York.
- Lot, serial or model codes
- GTIN 00840420124159, Lot Code: 1725563
- 510(k) numbers
- ["K051023"]
- 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