Z-2845-2016 Class II Terminated
FDA device recall Z-2845-2016 was initiated by Biomet 3I, LLC on Aug 8, 2016 and is designated Class II. Reason for recall: Product was incorrectly packaged. The recall status is terminated (terminated Aug 6, 2019). Affected quantity: 92 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 28, 2016
- Initiation Date
- Aug 8, 2016
- Termination Date
- Aug 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92 units
Product Description
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Reason for Recall
Product was incorrectly packaged.
Distribution Pattern
US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
Code Information
Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2845-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026