Device product
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Z-2845-2016
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 74896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92 units
- Official record key
device-enforcement:Z-2845-2016
Official wording
Reason: Product was incorrectly packaged.
Code information: Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.
Distribution pattern: US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
Derived failure modes
-
Unknown
Product was incorrectly packaged.