Recall Z-2395-2008 ยท GEY Motor, Surgical Instrument, Ac-Powered
Synthes U S A
Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.
| Date | Sep 21, 2008 (initiated Jul 23, 2008) |
| Status | Terminated |
| Reason | The product is mislabeled, as the validation for the previous sterilization parameters cannot be replicated. The currently validated sterilization parameter is a minium of 24 minutes prevacuum. |
| Root cause | Error in labeling |
| Action | All Synthes Trauma customers and sales consultant s were notified of the correction via return receipt letters sent via UPS. This notification communication contains product literature documenting the validated sterilization parameters. Instructions detail disposal of the previously received literature and replacement with the provided literature. A toll free number with a dedicated extension has been established for questions. The firm has requested that all recipients acknowledge understanding of instructions by returning a Verification Section via fax or email. If you have questions, call |
| Quantity | 584 units |
| Distribution | The product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.