Z-0631-2022Class II

ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA)...

Name: Z-0631-2022 ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA)...
Creator: DePuy Orthopaedics, Inc.
Published: 2022-01-05
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2022-01-05 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003 on 2022-01-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0631-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-05
Posted: 2022-02-09
Terminated: 2023-12-22
Recalling firm: Depuy Orthopaedics Inc.
Product: ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DePuy Synthesis issued Urgent Medical Device Recall Letter dated 1/5/22. Letter states reason for recall, health risk and action to take: 1. Carefully review the information contained in this notice. 2. Return the subject products using the normal returns process. Work with your sales consultant to ensure that the products are returned and to arrange for a replacement. To receive replacement product or reimbursement, customers must return the products subject to this notice. 3. Complete all fields of the attached Business Response Form. Please make sure to include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. The Business Response Form (BRF) must be completed and returned even if no subject product is in your possession. 4. Forward this notice to any personnel in your facility who need to be informed. 5. If any of the products subject to this notice have been forwarded to another facility, contact that facility and provide a copy of this notice to the relevant personnel. 6. Post a copy of this notice in a visible area for awareness of this notice. 7. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda. If you have any questions, please contact your local DePuy Synthes Sales Consultant.
Quantity in commerce: 6 units
Distribution: US Nationwide distribution in the states of TN, TX.
Product codes and lots: Lots: JH9651, JH9649 GTIN: 10603295383178

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0631-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0631-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-09
Z-0632-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-09

Product code JWH

K160700Class IIATTUNE Revision Knee SystemDepuy(Ireland) / cleared 2016-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)