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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach cutting burrs

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  Class 2 Device Recall Anspach cutting burrs see related information
Date Initiated by Firm May 18, 2007
Date Posted July 11, 2007
Recall Status1 Terminated 3 on January 17, 2009
Recall Number Z-1008-2007
Recall Event ID 37977
510(K)Number K061297  K011444  K965080  K955084  
Product Classification Cutting Burrs - Product Code HBB
Product Anspach Single Use, Sterile Bone Cutting Burrs
Code Information All cutting burrs packaged with an expiration date between June 2008 and august 2011.
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 white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days.
Quantity in Commerce 1,962,123
Distribution World wide-Distributed throughout the United States and to Puerto Rico, Canada, Mexico, Japan, Lithuania, Cyprus, Austrailia, England, Sweden, Bahamas, Korea, Germany, Switzerland, Malaysia, Iceland, Portugal, Singapore, Poland, Hungary, Thailand, Austria, Israel, Belgium, Egypt, South Africa, Netherlands, India, Syria, Kenya, Italy, Czech Republic, Jamaica, Columbia, Argentina, Honduras, Saudi Arabia, Greece, Finland, Taiwan, Republic of China, Lebanon, Denmark, France, Hong Kong, Philippines, Venezuela, Argintina, and the United Kingdom.
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 = HBB and Original Applicant = THE ANSPACH EFFORT, INC.