FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
- Recall number
- Z-0074-2013
- Recalling firm
- The Anspach Effort, Inc.
- Product
- "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
- Status
- Terminated
- Initiated
- 2012-01-09
- Posted
- 2012-10-18
- Terminated
- 2014-09-16
- Reason
- The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.
- Root cause
- Nonconforming Material/Component
- Action
- Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.
- Quantity
- 16 units
- Distribution
- Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.
- Lot, serial or model codes
- Serial Numbers: E31305311301, E31305311302, E31305311303, E31305311304, E31305311401, E31305311402, E31305311403, E31305311404, E31305311405, E32305311201, E32305311202, E33305311501, E33305311502, E33305311504, and E33305311505
- 510(k) numbers
- ["K011444","K080802"]
- PMA numbers
- not on file
- Product code
- HBE
- 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