Recall Z-1701-2017 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
| Date | Mar 8, 2017 |
| Status | Terminated |
| Reason | A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier |
| Root cause | Under Investigation by firm |
| Action | On March 13 Zimmer Biomet contacted their international consignee and asked them to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship within your territory along with a completed Attachment 1 Inventory Return Certification Form |
| Quantity | 5 |
| Distribution | Argentina |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE Implant Innovations, Inc., Apr 24, 2007 |