FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Synthes Small Electric Drive (SED). For use in general traumatology.
- Recall number
- Z-0747-2016
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Synthes Small Electric Drive (SED). For use in general traumatology.
- Status
- Terminated
- Initiated
- 2014-08-14
- Posted
- 2016-02-03
- Terminated
- 2016-02-05
- Reason
- The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
- Root cause
- Nonconforming Material/Component
- Action
- On 11/13/2014 DePuy Synthes send a letter to all their customers informing them of the recall of all the lots of the Small Electric Drive (SED) with instructions to returned and possible exchange. Contact is Complaint Handling Unit Manager at 561-494-3673
- Quantity
- 599 each
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA and HI, and the countries of Germany, Hong Kong, Chile, Israel, Poland, Italy, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, Netherlands, France, Japan, Sweden, Switzerland, Austria, China, India, Thailand, Russia, New Zealand, Zaire, Australia, Taiwan, and Malaysia.
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTC
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- 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