PlainRecalls
FDA Devices Moderate Class II Ongoing

stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Reported: April 10, 2024 Initiated: March 6, 2024 #Z-1477-2024

Product Description

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.

Details

Units Affected
47 units
Distribution
US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty. Recalled by Wright Medical Technology, Inc.. Units affected: 47 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1477-2024.