Devices

Device Recall AutoTac Delivery Handle

Model / Serial
Lot Numbers: 02070051, 04070030, 0800152, 06070018, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 1000003, 1001504, 1004620, 1101301, 1101802, 1103359, 1104032, 1104976, 1200616, and 1202282
Product Classification
Dental Devices
Device Class
2
Implanted device?
Yes
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.
Product Description
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. || Dental.
Manufacturer
BioHorizons Implant Systems Inc
1 Event
- Recall of Device Recall AutoTac Delivery Handle

Manufacturer

BioHorizons Implant Systems Inc

Manufacturer Address
BioHorizons Implant Systems Inc, 2300 Riverchase Ctr, Birmingham AL 35244-2808
Manufacturer Parent Company (2017)
Henry Schein Inc
Source
USFDA

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