FDA recall Z-0631-2022

Product

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

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-0631-2022