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ATTUNE recallZ-0631-2022 · DePuy Orthopaedics, Inc. · initiated Jan 5, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0631-2022
Status
Terminated
Initiated by the company
Jan 5, 2022
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
6 units
Product code
JWH
FDA submissions
K160700
Distribution
US Nationwide distribution in the states of TN, TX.

Product description

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

Code information (models, lots, serial numbers)

Lots: JH9651, JH9649 GTIN: 10603295383178

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

48 devices cleared under K160700 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89454).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page