Recall Z-0847-2014 ยท DZE Implant, Endosseous, Root-Form
Zimmer Dental Inc
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
| Date | Jan 28, 2014 (initiated Jan 6, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 307 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072589 | TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 Zimmer Dental, Inc., Oct 4, 2007 |