Medical device recalls Moderate risk

Implant Direct Sybron Manufacturing, LLC recalls Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

Recall date
July 21, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0007-2018
FDA classification
Class II
Brand / firm
Implant Direct Sybron Manufacturing, LLC
Sold / distributed
Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.

Why it was recalled

The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.

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

What was recalled

Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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