Recall Z-0074-2022 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DePuy Orthopaedics, Inc.
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
| Date | Sep 9, 2021 |
| Status | Terminated |
| Reason | Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery |
| Root cause | Under Investigation by 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 pro |
| Quantity | 10 units |
| Distribution | US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.