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Z-0561-2013 Class II Terminated

Recalled by BioHorizons Implant Systems Inc — Birmingham, AL

FDA device recall Z-0561-2013 was initiated by BioHorizons Implant Systems Inc on November 19, 2012 and is designated Class II. Reason for recall: The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. The recall status is terminated (terminated September 24, 2013). Affected quantity: 174 units.

Recall Details

Product Type: Devices
Report Date: December 26, 2012
Initiation Date: November 19, 2012
Termination Date: September 24, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 174 units

Product Description

AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Reason for Recall

The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

Distribution Pattern

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.

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

Other recalls by BioHorizons Implant Systems Inc

Z-0391-2016 Class II — RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx onl (October 30, 2015)
Z-1605-2015 Class II — Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage U (April 16, 2015)
Z-1058-2014 Class II — External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx On (December 10, 2013)
Z-0562-2013 Class II — Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMI (November 19, 2012)