ClearanceBrief
Recall Z-1243-03 ยท HBC Motor, Drill, Electric

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)

DateOct 15, 2003 (initiated Apr 23, 2003)
StatusTerminated
ReasonFaulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
Root causeOther
ActionA recall notification letter was mailed to domestic consignees and faxed to international consignees on April 23, 2003. The letter requests return of the devices.
Quantity24
DistributionThe 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K011444ANSPACH EMAX DRILL SYSTEM
The Anspach Effort, Inc., Aug 8, 2001