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Recall Observatory FDA recall evidence

Device product

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Z-1477-2024

March 06, 2024

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 94194
Status
Ongoing
Classification
Class II
Quantity
47 units
Official record key
device-enforcement:Z-1477-2024

Official wording

Reason: 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.

Code information: UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.