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.
Take action
Contact the company
📍Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994
“DePuy ATTUNE Revision Femoral Augment Recall: Adhesive Residue Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61316-depuy-attune-revision-femoral-augment-recall-adhesive-residue-risk. Based on FDA recall #Z-0631-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0631-2022%22&limit=1).
The FDA announced on Jan. 5, 2022, that DePuy Orthopaedics, Inc. recalled the ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM due to potential adhesive residue causing soft tissue irritation or infection. The agency classified the recall as Class II.
The device may have adhesive residue on the posterior surface of the femoral augment. If undetected prior to implantation, this residue may cause soft tissue irritation and/or infection.
Context
GovInfoNow's records show DePuy Orthopaedics, Inc. has 23 other recalls on record since July 12, 2017. Recent brand recalls include an ATTUNE Knee Component recall due to incorrect labeling on March 12, 2024, and a Posterior Tibial Insert recall regarding gamma radiation dose risk on Feb. 15, 2023. Other recent recalls of similar products include Depuy ATTUNE Revision Hinge Femoral LT SZ 5 CEM (April 3, 2026), Depuy ATTUNE Revision Hinge Femoral LT SZ 8 CEM (April 3, 2026), and Depuy ATTUNE Revision Hinge Femoral RT SZ 8 CEM (April 3, 2026).
How to tell if you have this one
Check if your knee surgery component has the product number 154909003 and lots JH9651 or JH9649. This part is used in revision total knee replacements.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of TN, TX.
Recall number
Product, codes & lots
Quantity
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; Lots: JH9651, JH9649 GTIN: 10603295383178
6 units
Z-0632-2022
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001; Lots: JJ3389 GTIN: 10603295382775
3 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify your component's product number (154909003) and lot numbers (JH9651 or JH9649) to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of TN, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Tennessee, Texas.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0631-2022 (January 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0631-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.