Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
FDA device recall Z-2144-2014 · posted 2014-08-02 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- 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."
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 291 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.
- Date initiated
- 2014-07-17
- Date posted
- 2014-08-02
- Date terminated
- 2015-02-06
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT (K013227) | Sulzer Dental, Inc. | 2001-11-19 |
| SCREW-VENT DENTAL IMPLANT SYSTEM (K011028) | Sulzer Dental, Inc. | 2001-05-21 |