Recall Z-1190-2018 ยท DZE Implant, Endosseous, Root-Form
Zimmer Dental Inc
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
| Date | Mar 5, 2018 (initiated Nov 29, 2017) |
| Status | Terminated |
| Reason | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled. |
| Root cause | Packaging process control |
| Action | On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form. Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affec |
| Quantity | 995 distribution events total |
| Distribution | Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072589 | TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 Zimmer Dental, Inc., Oct 4, 2007 |