TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is
FDA device recall Z-2051-2015 · posted 2015-07-08 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
- Action taken
- 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, Monument, CO 80132. Send a copy of the completed Verification Section even if you do not have any product to DePuy Synthes by: Fax: (610) 430-7083 or Scan/email: Fieldaction@synthes.com Number. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JDS
- Quantity affected
- 3
- Distribution
- US Distribution to states of: MO and SC.
- Date initiated
- 2015-06-03
- Date posted
- 2015-07-08
- Date terminated
- 2015-09-15
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES (USA) TIBIAL NAIL SYSTEM EX (K040762) | Synthes (Usa) | 2004-04-12 |