Medical device recalls Moderate risk

Zimmer Dental Inc recalls Tapered SwissPlus Implant System, Model No. SPB10

Recall date
March 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1823-2017
FDA classification
Class II
Brand / firm
Zimmer Dental Inc
Sold / distributed
Worldwide: ZA, FR, IT, IR

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tapered SwissPlus Implant System, Model No. SPB10

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