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U.S. Department of Health and Human Services

Class 2 Device Recall Foot Pedal

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  Class 2 Device Recall Foot Pedal see related information
Date Initiated by Firm August 13, 2009
Date Posted October 28, 2009
Recall Status1 Terminated 3 on January 05, 2010
Recall Number Z-0083-2010
Recall Event ID 53073
510(K)Number K080802  K011444  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP.

Indicated to cut and shape bone including bones of the spine and cranium.
Code Information EMAX2-FP Serial Numbers: C26302250301, C26302250302, C26302250303, C26302250304, 5044044307, 31495607, 32380602, 31832209, 31832202 and 32366805; and  EPLUS-FP Serial Numbers: C26302200804 , C26302200802, C27302221701 and C08301701901.
Recalling Firm/
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact
561-627-1080 Ext. 500
Manufacturer Reason
for Recall
The Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the connector body. The lack of shielding may result in radiated emissions which could possibly cause interference on other electrical equipment adjacent to the foot pedal
FDA Determined
Cause 2
Device Design
Action Anspach issued an "Urgent Product Removal" Letter dated August 17, 2009 informing customers of the affected product. Consignees are asked to screen their inventory and return any affected product including a completed Product Replacement Form to the firm. For further questions, contact Anspach at 1-800-327-6887 or 1-561-627-1080.
Quantity in Commerce 14
Distribution Worldwide Distribution -- Canada, Indonesia, United Kingdom, Korea and United States (NC, OK, TN, CA, KS, MI and WA).
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HBE and Original Applicant = THE ANSPACH EFFORT, INC.