ATTUNE recallZ-0074-2022 · DePuy Orthopaedics, Inc. · initiated Sep 9, 2021
Terminated
Is my device affected?
- 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.
- 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.
- 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
Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
FDA root cause category: Under Investigation by firm
What the company is doing
DePuy (Ireland) issued Urgent Medical Device Recall (Removal)letter via email to US Sales Offices/Distributors and US Hospitals on 9/9/21. Recall letters will be emailed to US Sales Offices/Distributors. US Hospitals will be contacted by sales consultants. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject lot and quarantine the product. 2. Return the subject product(s) using the normal returns process. Work with your sales consultant to return subject product(s) and to replace. To receive replacement product(s) or reimbursement, customers must return the products subject to this removal. 3. Review, complete all fields, sign, and return the attached business response form (BRF) on page 2 of this letter to [email protected] within three (3) business days of receipt of this Removal Letter. Please include in the email subject: FA 2010228 - ATTUNE Revision Tibial Augment Incorrect Screw Size Packaged. 4. Forward this Removal Letter to any personnel in your facility who need to be informed. 5. If any of the product(s) subject to this Removal have been forwarded to another facility, contact that facility and provide a copy of this Removal Letter to the relevant personnel. 6. Post a copy of this Removal Letter in a visible area for awareness of this Removal. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.
Recall details
- Recall number
- Z-0074-2022
- Status
- Terminated
- Initiated by the company
- Sep 9, 2021
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 10 units
- Product code
- JWH
- Distribution
- US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.
Product description
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Code information (models, lots, serial numbers)
Lot Number: J6304Z GTIN: 10603295057642
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ATTUNE 1523-07-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall9 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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