Z-0140-2023Class II

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4

Name: Z-0140-2023 Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Creator: Wright Medical Technology, Inc.
Published: 2022-09-30
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2022-09-30 / Open, Classified / root cause: design

FDA source

Wright Medical Technology, Inc. began a recall of Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4 on 2022-09-30. FDA classified it as Class II and gives the reason as "The tibial tray lock detail is oversized (larger than specification)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0140-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-30
Posted: 2022-10-27
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
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: The tibial tray lock detail is oversized (larger than specification).
Root cause tag: design
FDA 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 in commerce: 1 unit
Distribution: US Nationwide distribution in the state of New York.
Product codes and lots: GTIN 00840420124159, Lot Code: 1725563

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0140-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0139-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-02	2022-10-27
Z-0140-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-02	2022-10-27

Product code HSN

K051023Class IITopez Total Ankle ReplacementTopez Orthopedics, Inc. / cleared 2005-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)