Medical device recalls Moderate risk

Ace Surgical Supply Co., Inc. recalls INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage:…

Recall date
February 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1835-2017
FDA classification
Class II
Brand / firm
Ace Surgical Supply Co., Inc.
Sold / distributed
Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.

Why it was recalled

Incorrect device was packaged.

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

What was recalled

INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

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