FDA-Device2017-04-26Class II

Tapered SwissPlus Implant System, Model No. SPB10

Zimmer Dental Inc
Hazard

It was manufactured with the minor diameter of the internal thread that is below specification.

Sold states
Worldwide: ZA, FR, IT, IR
Affected count
188 units
Manufactured in
1900 Aston Ave, N/A, Carlsbad, CA, United States
Products
Tapered SwissPlus Implant System, Model No. SPB10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2017

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