Recall Z-0153-2015 ยท DZE Implant, Endosseous, Root-Form
Zimmer Dental Inc
Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
| 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
| K093164 | 3.25 SPLINE TWIST IMPLANT, HA COATED Zimmer Dental, Inc., Dec 15, 2009 |