Z-1477-2024Class II

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Name: Z-1477-2024 stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Creator: Wright Medical Technology, Inc.
Published: 2024-03-06
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2024-03-06 / Open, Classified

FDA source

Wright Medical Technology, Inc. began a recall of stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty on 2024-03-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1477-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-06
Posted: 2024-04-04
Recalling firm: Wright Medical Technology Inc
Product: stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: 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.
FDA 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 [email protected].
Quantity in commerce: 47 units
Distribution: US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
Product codes and lots: UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1477-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1477-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-04

Product code HSN

K123954Class IIInfinity Total Ankle SystemWrightmedicaltechnologyinc / cleared 2013-04-01

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)