—#191624

Product

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

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K160700
Affected lot / code info: Lots: JJ3389 GTIN: 10603295382775

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: US Nationwide distribution in the states of TN, TX.

Timeline

Recall initiated: 2022-01-05
Terminated: 2023-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191624. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.