FDAFDA · Food and drugs·Recall number Z-0847-2014
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
Published February 5, 2014 · Recall initiated: January 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer Dental Inc
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.
- Lot
- Catalog Number TSVWB11, Lot 62470008.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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