Recall Z-2144-2014 ยท DZE Implant, Endosseous, Root-Form
Zimmer, Inc.
Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
| Date | Aug 2, 2014 (initiated Jul 17, 2014) |
| Status | Terminated |
| Reason | Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm." |
| Root cause | Process design |
| Action | A recall letter dated 7/22/14 was sent to all customers who purchased the Tapered Screw-Vent Implant to inform them of the recall by Zimmer Dental. The letter informs the customers of the problems identified, risks involved, and the actions to be taken. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, 7-5pm, Mon-Fri. Customers are instructed to complete the customer response form and e-mail a copy to corporatequality.postmarket@zimmer.com or fax to (574) 372-4265. |
| Quantity | 291 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan. |
| FDA record | Open on fda.gov |