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ATTUNE recallZ-2348-2021 · DePuy Orthopaedics, Inc. · initiated Jul 1, 2021

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

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

FDA root cause category: Process change control

What the company is doing

DePuy Syntheses issued Medical Device Product Recall (Removal) Ref. 1986537 dated 7/1/21. Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1.Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. 2.Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical returns process in order to acquire a return number prior toshipping product. 3.Review, complete, sign, and return the attached business response form (page 3 of this letter) to your localDePuy Synthes sales organization in accordance with the directions on the form within 5 business days ofreceipt of this notification. 4.Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport,store, stock, or use the devices subject to this action). 5.If any of the subject lot has been forwarded to another facility, contact that facility and provide them with thisnotice. 6.Post a copy of this notice in a visible area for awareness and keep a copy for your records. Should you have any other inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant.

Recall details

Recall number
Z-2348-2021
Status
Terminated
Initiated by the company
Jul 1, 2021
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
7 units
Product code
JWH
FDA submissions
K160700
Distribution
International distribution in the countries of Canada, France.

Product description

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

Code information (models, lots, serial numbers)

Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010

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.

Sources and updates

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