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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Power Drive.

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 Class 2 Device Recall Synthes Power Drive.see related information
Date Initiated by FirmJuly 23, 2008
Date PostedSeptember 21, 2008
Recall Status1 Terminated 3 on May 05, 2009
Recall NumberZ-2395-2008
Recall Event ID 49039
Product Classification Motor, surgical instrument, ac-powered - Product Code GEY
ProductPower Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.
Code Information Catalog number 530.100. All lot numbers
FEI Number 3005180112
Recalling Firm/
Manufacturer		 Synthes U S A
1302 Wrights Ln
West Chester PA 19380-3401
For Additional Information ContactSales Consultant
800-620-7025 Ext. 5450
Manufacturer 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 2		Error in labeling
ActionAll 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.
Quantity in Commerce584 units
DistributionThe product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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