Recall Z-1419-2022 ยท HWT Template
DePuy Orthopaedics, Inc.
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
| Date | Jun 29, 2022 |
| Status | Open, Classified |
| Reason | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain |
| Root cause | Process control |
| Action | DePuy Synthes issued Urgent Medical Device Correction Letter on June 29 2022. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately for the subject lots and quarantine the products. 2. To minimize disruption, replacement of the spring will be completed by a Field Service Representative. You will be contacted directly by a member of the Field Service Team. 3. Familiarize yourself with the content of this letter and forward this notice to any personnel in your facility who need to be informed. 4. Complete all fields, sign, and return the attached |
| Quantity | 872 units |
| Distribution | Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Per |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.