Medical device recalls Moderate risk

DePuy Orthopaedics, Inc. recalls ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

Recall date
September 9, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0074-2022
FDA classification
Class II
Brand / firm
DePuy Orthopaedics, Inc.
Sold / distributed
US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.

Why it was recalled

Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery

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 Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

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