FDA-Device2024-04-10Class II
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Wright Medical Technology, Inc.
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.
Sold states
US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
Affected count
47 units
Manufactured in
1023 Cherry Rd, Memphis, TN, United States
Products
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1477-2024Don't want to check this manually?
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