Z-2395-2008

Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to...

Name: Z-2395-2008 Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to...
Creator: Synthes U S A
Published: 2008-07-23
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2008-07-23 / Terminated / root cause: labeling and UDI

FDA source

Synthes U S A began a recall of Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments on 2008-07-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2395-2008
Status: Terminated
Initiated: 2008-07-23
Posted: 2008-09-21
Terminated: 2009-05-05
Recalling firm: Synthes GmbH
Product: Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.
Product code: GEY Motor, Surgical Instrument, Ac-Powered
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.
Root cause tag: labeling and UDI
FDA 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 800-620-7025 ext 5450, 610-719-5450 or contact your Synthes Sales Consultant.
Quantity in commerce: 584 units
Distribution: The product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada.
Product codes and lots: Catalog number 530.100. All lot numbers

Product code GEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)