Recall Z-1246-2023 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes (USA) Products LLC
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
| Date | Mar 10, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| Reason | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length |
| Root cause | Under Investigation by firm |
| Action | DePuy Synthes issued Urgent Medical Device Recall (Removal) on 2/1/23 to US accounts. Canada and Japan and the affiliates in-country executing the recall per their local regulations. Letter states reason for recall, health risk, and action to take: Examine your inventory immediately to determine if you have the subject products and quarantinethem immediately. 2.Contact your DePuy Synthes Sales Consultant or customer support services at ra-dpyus-csspecial@its.jnj.com to coordinate the return/credit of the subject products. 3.Review, complete, sign, and return the attached Business Response For |
| Quantity | 6 units |
| Distribution | Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131548 | SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM Synthes (USA) Products, LLC, Feb 28, 2014 |