DePuy Orthopaedics, Inc. recalls ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
- Recall date
- July 1, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2348-2021
- FDA classification
- Class II
- Brand / firm
- DePuy Orthopaedics, Inc.
- Sold / distributed
- International distribution in the countries of Canada, France.
Why it was recalled
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
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