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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.
Brand
Synthes U S A
Lot Codes / Batch Numbers
Catalog number 530.100. All lot numbers
Products Sold
Catalog number 530.100. All lot numbers
Synthes U S A is recalling Power Drive. Battery-driven power tool system intended for use during surgical procedures to provid due to The product is mislabeled, as the validation for the previous sterilization parameters cannot be replicated. The currently validated sterilization pa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026