Recall Z-0284-2018 ยท DZE Implant, Endosseous, Root-Form
Zimmer Dental Inc
Tapered Screw-Vent MTX Model TSVTB11
| Date | Nov 20, 2017 |
| Status | Terminated |
| Reason | Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition. |
| Root cause | Under Investigation by firm |
| Action | Recall notification letters will be sent to distributors and clinicians on or about the last week of November 2017. International distributors will be notified via courier or email. Clinicians will be instructed to; 1. Follow any specified patient monitoring instructions, 2. Return Attachment 1 (Acknowledgment of Responsibility) to Zimmer Biomet, 3. Review their inventory and returning any affected product. |
| Quantity | 500 units |
| Distribution | US, Canada, France, Italy, Spain, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101977 | TAPERED SCREW-VENT T IMPLANT Zimmer Dental, Inc., Sep 14, 2010 |