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

Recall date

March 6, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1477-2024

FDA classification

Class II

Brand / firm

Wright Medical Technology, Inc.

Sold / distributed

US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty