FDA Enforcement
Class II
Terminated
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Recall: Z-2845-2016
·
Reported September 28, 2016
Enforcement
- Recall Number
- Z-2845-2016
- Event ID
- 74896
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomet 3i, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 28, 2016
- Initiation Date
- August 8, 2016
- Classification Date
- September 19, 2016
- Termination Date
- August 6, 2019
- Address
- 4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200, United States
Description
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Reason
Product was incorrectly packaged.
Code Info
Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.
Distribution
US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
Quantity
92 units