FDA recall Z-1477-2024

Wright Medical Technology, Inc. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2024-03-06
Report date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1477-2024