FDA-Device2014-11-05Class II
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth
Zimmer Dental Inc
Hazard
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Sold states
Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
Affected count
1,044 units
Manufactured in
1900 Aston Ave, N/A, Carlsbad, CA, United States
Products
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0154-2015Don't want to check this manually?
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