Recall Z-2050-2014 ยท DZE Implant, Endosseous, Root-Form
Zimmer, Inc.
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
| Date | Jul 14, 2014 (initiated Jun 25, 2014) |
| Status | Terminated |
| Reason | Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial. |
| Root cause | Under Investigation by firm |
| Action | Recall notification letters sent to customers on 06/25/14. The recall letter, titled "URGENT DEVICE RECALL NOTICE", delivered to customers via a courier, with instructions for returning any unused affected product. The recall letter was accompanied with a response form and provided the following information to customers: product information with codes, reason for recall, risks, responsibilities, MedWatch Reporting and contacting information. |
| Quantity | 129 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |