FDA-Device2014-02-05Class II
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
Zimmer Dental Inc
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.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.
Affected count
307
Manufactured in
1900 Aston Ave, Carlsbad, CA, United States
Products
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0847-2014Don't want to check this manually?
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