FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
- Recall number
- Z-0631-2014
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
- Status
- Terminated
- Initiated
- 2012-06-11
- Posted
- 2014-01-06
- Terminated
- 2016-04-18
- Reason
- Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).
- Root cause
- Unknown/Undetermined by firm
- Action
- none
- Quantity
- 4 ( BLACKMAX-N) and 1 (Foot Control)
- Distribution
- US Distribution: Maryland only.
- Lot, serial or model codes
- Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEY
- 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