stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
FDA Recall #Z-1477-2024 — Class II — March 6, 2024
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.
Recalling Firm
Wright Medical Technology, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
47 units
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated