Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mm
FDA device recall Z-0154-2015 · posted 2014-10-30 · Terminated
Recall details
- Recalling firm
- Zimmer Dental Inc
- Reason for recall
- Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 1,044 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
- Date initiated
- 2014-10-01
- Date posted
- 2014-10-30
- Date terminated
- 2015-04-28
- Location
- Carlsbad, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 (K072589) | Zimmer Dental, Inc. | 2007-10-04 |