FDAClass IIApril 10, 2024

stryker Infinity Resection Adjustment Block recall

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Why was stryker Infinity Resection Adjustment Block 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Recalling firm
Wright Medical Technology, Inc.
Quantity
47 units
Distribution
US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
Recall date
April 10, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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