Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k)
FDA device recall Z-0847-2014 · posted 2014-01-28 · Terminated
Recall details
- Recalling firm
- Zimmer Dental Inc
- Reason for recall
- Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead of 4.7 x 11.5mm.
- Action taken
- Zimmer Dental initiated the recall on 01/06/2013 by sending out recall notifications via FedEx to domestic customers and via electric mail to international customers. Customers are sent a letter identifying the issue, product description with codes, risk, instructions, and contact information. The letter's instructions include locating the affected product and return unused product to Zimmer Dental and notifying the amount of product that has been consumed.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 307
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.
- Date initiated
- 2014-01-06
- Date posted
- 2014-01-28
- Date terminated
- 2014-07-07
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |