Recall Z-2425-2015 ยท FSM Tray, Surgical, Instrument
Synthes (USA) Products LLC
Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital.
| Date | Aug 20, 2015 (initiated Jul 1, 2015) |
| Status | Terminated |
| Reason | The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item. |
| Root cause | Under Investigation by firm |
| Action | DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated July 8, 2015, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS REQUIRED We have on record that your facility has received the product(s) subject to this recall. DePuy Synthes asks that you review your inventory and immediately remove the affected lots from your stock. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Aut |
| Quantity | 1487 |
| Distribution | Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Canada, Switzerland and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.