Recall Z-2845-2016 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
| Date | Aug 8, 2016 |
| Status | Terminated |
| Reason | Product was incorrectly packaged. |
| Root cause | Packaging process control |
| Action | An Urgent Medical Device Removal Notice is being sent to Customers August 12, 2016, notifying them of the packaging of OSSEOTITE Certain Implant (4x11.5mm) in T3 Implant boxes. This recall is specific to Lot No. 2016031461. The material shipped within the box was described as being correct ,but only the box it was shipped in was incorrect. Customers were notified that there are no immediate or long term health consequences. In the notification letter, customers are instructed to complete the Certificate of Acknowledgement, and to return it via email (postmarket@zimmerbiomet.com) if no product |
| Quantity | 92 units |
| Distribution | US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS Implant Innovations, Inc., Apr 30, 2007 |