Recall Z-1264-2023 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
DePuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
| Date | Mar 17, 2023 (initiated Feb 15, 2023) |
| Status | Open, Classified |
| Reason | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. |
| Root cause | Labeling Change Control |
| Action | An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification letter dated 2/14/23 was delivered to customers. Please Take the Following Steps: 1. Examine your inventory immediately to determine if you have the subject products and quarantine the subject products. DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (See page 3 of this communication) to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this notificat |
| Quantity | 7 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191779 | Attune Revision LPS Inserts Depuy(Ireland), Oct 8, 2019 |