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Terminated

ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

FDA Recall Z-0074-2022 · Posted None

Recall StatusTerminated
Product CodeJWH
Date Initiated2021-09-09
Date Terminated2023-08-09
Product Quantity10 units

Reason for Recall

Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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