Wright Medical Technology, Inc.: stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

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.

Details from the source

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: US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK Quantity: 47 units Lot/code info: UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094

UPC codes

00889797004008

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.