Medical device recalls Moderate risk

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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