FDA-Device2018-04-04Class II
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Zimmer Dental Inc
Hazard
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Sold states
Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
Affected count
995 distribution events total
Manufactured in
1900 Aston Ave, Carlsbad, CA, United States
Products
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1190-2018Don't want to check this manually?
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