FDAFDA · Food and drugs·Recall number Z-0631-2022
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
Published February 16, 2022 · Recall initiated: January 5, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- US Nationwide distribution in the states of TN, TX.
- Lot
- Lots: JH9651, JH9649 GTIN: 10603295383178
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.