FDA Medical Device Recalls (openFDA)
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 number
- Z-2395-2008
- Recalling firm
- Synthes U S A
- Product
- Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.
- Status
- Terminated
- Initiated
- 2008-07-23
- Posted
- 2008-09-21
- Terminated
- 2009-05-05
- Reason
- 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
- 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
- 584 units
- Distribution
- The product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada.
- Lot, serial or model codes
- Catalog number 530.100. All lot numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEY
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28