Recall Z-2395-2008
Synthes U S A · initiated July 23, 2008
Product
Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.
Codes / lots: Catalog number 530.100. All lot numbers
Reason for recall
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.
FDA-determined cause: Error in labeling
Action taken
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 800-620-7025 ext 5450, 610-719-5450 or contact your Synthes Sales Consultant.
Details
- Recall number
- Z-2395-2008
- Initiated
- July 23, 2008
- Posted by FDA
- September 21, 2008
- Terminated
- May 5, 2009
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Quantity
- 584 units
- Distribution
- The product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada.
- Recalling firm
- Synthes U S A, West Chester, PA