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)
This recall has been terminated (originally issued October 15, 2003).
- Company
- The Anspach Effort, Inc.
- Recall Initiated
- April 23, 2003
- Posted
- October 15, 2003
- Terminated
- September 22, 2003
- Recall Number
- Z-1243-03
- Quantity
- 24
- Firm Location
- Palm Beach Gardens, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
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 / Code Info
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
Root Cause
Other
Action Taken
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.