Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.
FDA Recall Z-2395-2008 · Posted 2008-09-21
Advertisement
Recalling FirmSynthes U S A
Recall StatusTerminated
Product CodeGEY
Date Initiated2008-07-23
Date Terminated2009-05-05
Product Quantity584 units
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.
Firm 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 800-620-7025 ext 5450, 610-719-5450 or contact your Synthes Sales Consultant.
Root Cause
Error in labeling
Distribution Pattern
The product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement