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U.S. Department of Health and Human Services

Class 2 Device Recall ANSPACH Electric System Foot Control with Direction and Irrigation

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  Class 2 Device Recall ANSPACH Electric System Foot Control with Direction and Irrigation see related information
Date Initiated by Firm January 09, 2012
Date Posted October 18, 2012
Recall Status1 Terminated 3 on September 16, 2014
Recall Number Z-0076-2013
Recall Event ID 63086
510(K)Number K080802  K011444  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product "***Electric Systems Foot Control with Direction and Irrigation***Rx Only***"

Product Usage:
Cutting and shaping bone including bones of the spine and cranium.
Code Information Serial Numbers: E3230327501, E32305327502, E32305327503, E32305327504, E32305327505, E32305327601, E32305327602, E32305327603, E32305327604, and E32305327605
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Aimee Hamilton
561-627-1080
Manufacturer Reason
for Recall		 The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.
Quantity in Commerce 10 units
Distribution Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.
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.
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