FDA-Device2022-02-16Class II

ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003

DePuy Orthopaedics, Inc.
Hazard

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

Sold states
US Nationwide distribution in the states of TN, TX.
Affected count
6 units
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0631-2022

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