FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Synthes Small Electric Drive (SED)
- Recall number
- Z-1017-2016
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Synthes Small Electric Drive (SED)
- Status
- Open, Classified
- Initiated
- 2014-11-14
- Posted
- 2016-02-25
- Terminated
- not on file
- Reason
- May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
- Root cause
- Other
- Action
- On November 13, 2014 DePuySynthes sent a letter to all their consignees informing them of the recall and asked them to return the product. A letter and a response letter were sent to all customers that received the device. For contact - The Complaint Handling Unit Manager at 561-494-3673 or the customer DePuy Synthes Sales Consultant.
- Quantity
- 302 (23 in the USA and 279 OUS)
- Distribution
- CO, FL, LA, ID, CA, KS, IL, TX, VA, MI, NC, WA, AR, NY, NC, AZ, and Hawaii Canada, Hong Kong, Chile, Israel, Poland, Turkey, Itly, Malaysia, Ireland, Korea, Germany, Spain, Norway, Sweeden, England, Fiji, Switzerland, Belgium, Austria, Netherlands, France, Japan, China, India, Thailand, Russia, Zaire, Taiwan, and Australia.
- Lot, serial or model codes
- All lots from production launch
- 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