FDA recall Z-0632-2022

Product

ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001

Reason for recall

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.

Distribution

US Nationwide distribution in the states of TN, TX.

Key facts

Status

Terminated

Initiation date

2022-01-05

Report date

2022-02-16

Termination date

2023-12-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0632-2022