Recalls / —

—#189395

Product

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

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

Affected lot / code info

Lot Number: J6304Z GTIN: 10603295057642

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 OneMD-Field-Actions@its.jnj.com 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.

Recalling firm

Firm

DePuy Orthopaedics, Inc.

Address

700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern

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

Timeline

Recall initiated

2021-09-09

Terminated

2023-08-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #189395. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.