ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Summary
The FDA issued a Class II for ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplast by DePuy Orthopaedics, Inc.. Reason: Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement.
Details
Source
Device Recall
External ID
Z-2348-2021
Action Date
2021-09-01
Status
Terminated
Category
device
Product Description
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Lot/Code Info: Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010
Quantity Affected: 7 units
Reason for Recall
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Distribution
International distribution in the countries of Canada, France.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-01
Company
Warsaw, IN
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 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 clearances.
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 (DePuy Orthopaedics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DePuy Orthopaedics, Inc. have FDA actions?
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2348-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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