Recall Z-2051-2015 ยท JDS Nail, Fixation, Bone
Synthes, Inc.
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
| Date | Jul 8, 2015 (initiated Jun 3, 2015) |
| Status | Terminated |
| Reason | A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection. |
| Root cause | Employee error |
| Action | The firm, Depuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" notification letter, dated June 3, 2015, to direct accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove the affected lots from your stock; 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 Authorization (RA)Complete and Return the Verification Section with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Mon |
| Quantity | 3 |
| Distribution | US Distribution to states of: MO and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040762 | SYNTHES (USA) TIBIAL NAIL SYSTEM EX Synthes (Usa), Apr 12, 2004 |