Medical device recalls Moderate risk

Ace Surgical Supply Co., Inc. recalls Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

Recall date
March 28, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1464-2018
FDA classification
Class II
Brand / firm
Ace Surgical Supply Co., Inc.
Sold / distributed
US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,

Why it was recalled

The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.

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

What was recalled

Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

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