Medical device recalls Moderate risk

Implant Direct Sybron Manufacturing, LLC recalls GoDirect Screw-Retaining Top Part Numbers: 4500-61

Recall date
November 28, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0961-2017
FDA classification
Class II
Brand / firm
Implant Direct Sybron Manufacturing, LLC
Sold / distributed
U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.

Why it was recalled

Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

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

What was recalled

GoDirect Screw-Retaining Top Part Numbers: 4500-61

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