FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)
- Recall number
- Z-1243-03
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)
- Status
- Terminated
- Initiated
- 2003-04-23
- Posted
- 2003-10-15
- Terminated
- 2003-09-22
- Reason
- Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
- Root cause
- Other
- Action
- A recall notification letter was mailed to domestic consignees and faxed to international consignees on April 23, 2003. The letter requests return of the devices.
- Quantity
- 24
- Distribution
- The devices were distributed to 12 domestic hosptials in FL, GA, NC, TX, CA, MA, MS as well as three international accounts in Taiwan, South Africa and Italy.
- Lot, serial or model codes
- Serial Numbers: 50139962-2, 50128299-4, 50139968-5, 50139963-5, 50116580-5, 50128299-5, 50139964-2, 50139962-1, 50139971-2, 50139968-1, 50139964-3, 50128295-2, 50139964-1, 50139968-2, 50139964-4, 50128299-3, 50116576-2, 50128299-2, 50139968-3, 50139963-2, , 50139968-4, 50139963-4, 114766-1,114766-2
- 510(k) numbers
- K011444
- PMA numbers
- not on file
- Product code
- HBC
- 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