Device product
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Z-1477-2024
Product summary
- Event
- Event 94194
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 47 units
- Official record key
device-enforcement:Z-1477-2024
Official wording
Reason: 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.
Code information: UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094
Distribution pattern: US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
Derived failure modes
-
Unknown
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.