stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Summary
The FDA issued a Class II for stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty by Wright Medical Technology, Inc.. Reason: Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were foun.
Details
Source
Device Recall
External ID
Z-1477-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Lot/Code Info: UDI/DI 00889797004008, Lot Numbers: 2656950, 2762126, 2796094
Quantity Affected: 47 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-06
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wright Medical Technology, Inc. has 21 FDA actions in our database, including 21 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wright Medical Technology, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wright Medical Technology, Inc. have FDA actions?
Wright Medical Technology, Inc. has 21 FDA actions in our database, including 21 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1477-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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