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U.S. Department of Health and Human Services

Class 2 Device Recall AutoTac Delivery Handle

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 Class 2 Device Recall AutoTac Delivery Handle see related information
Date Posted December 19, 2012
Recall Status1 Terminated on September 24, 2013
Recall Number Z-0561-2013
Recall Event ID 63744
510(K)Number K993493 
Product Classification Implant, endosseous, root-form - Product Code DZE
Product AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244.

Code Information Lot Numbers: 02070051, 04070030, 0800152, 06070018, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 1000003, 1001504, 1004620, 1101301, 1101802, 1103359, 1104032, 1104976, 1200616, and 1202282
Recalling Firm/
BioHorizons Implant Systems Inc
2300 Riverchase Ctr
Birmingham AL 35244-2808
For Additional Information Contact Winston Greer
Manufacturer Reason
for Recall
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
FDA Determined
Cause 2
Component design/selection
Action BioHorizons sent an "URGENT DEVICE CORRECTION" letter on November 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact the Customer Care Department at (888) 246-8338 for questions regarding this recall.
Quantity in Commerce 174 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Ecuador, Egypt, Fiji, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.