Device product
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Z-1411-2015
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 70628
- Status
- Terminated
- Classification
- Class II
- Quantity
- 620 implants in total
- Official record key
device-enforcement:Z-1411-2015
Official wording
Reason: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Code information: Implant PN # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018
Distribution pattern: Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
Derived failure modes
-
Unknown
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.