Recall Z-0154-2015 ยท DZE Implant, Endosseous, Root-Form
Zimmer Dental Inc
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth
| Date | Oct 30, 2014 (initiated Oct 1, 2014) |
| Status | Terminated |
| Reason | Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial. |
| Root cause | Labeling Change Control |
| Action | Customer Notification letters dated 10/6/14 were sent to all customers who purchased the Tapered Screw Vent Implant and the Spline Twist Implant because the incorrect diameter size was printed on the inner vial. The letters informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached Business Reply Form and fax it to (574) 372-4265 or email to corporatequality.postmarket@zimmer.com. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019 from 7am-5pm, Monday-Friday. |
| Quantity | 1,044 units |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan. |
| 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 |