Z-1243-03

Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the...

Name: Z-1243-03 Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the...
Creator: The Anspach Effort, Inc.
Published: 2003-04-23
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2003-04-23 / Terminated

FDA source

The Anspach Effort, Inc. began a recall of 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... on 2003-04-23. The reason FDA records is "Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1243-03
Status: Terminated
Initiated: 2003-04-23
Posted: 2003-10-15
Terminated: 2003-09-22
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)
Product code: HBC Motor, Drill, Electric
Reason for recall: Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code HBC

K011444Class IIAnspach Emax Drill SystemThe Anspach Effort, Inc. / cleared 2001-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)