Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Anspach eMax Drill System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Anspach eMax Drill Systemsee related information
Date Initiated by FirmApril 23, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on September 22, 2003
Recall NumberZ-1243-03
Recall Event ID 26308
510(K)NumberK011444 
Product Classification Motor, Drill, Electric - Product Code HBC
ProductProduct 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)
Code Information 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
FEI Number 1045834
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens FL 33410
For Additional Information ContactWilliam G. Conety
800-327-6887
Manufacturer Reason
for Recall		Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
FDA Determined
Cause 2		Other
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.
Quantity in Commerce24
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HBC
-
-