FDAFDA · Food and drugs·Recall number Z-1477-2024
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Published April 10, 2024 · Recall initiated: March 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Wright Medical Technology, Inc.
- Distributor
- US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
- Lot
- UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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