Z-1477-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2024
- Initiation Date
- March 6, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 units
Product Description
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
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.
Distribution Pattern
US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
Code Information
UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094