Medical device recalls Moderate risk

Amendia, Inc recalls Optimus Fixed Awl

Recall date
November 22, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0891-2017
FDA classification
Class II
Brand / firm
Amendia, Inc
Sold / distributed
US Distribution to the states of : FL, GA. IL, MO, TX

Why it was recalled

Complaints that the tip of the awl broke after impaction during surgery.

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

What was recalled

Optimus Fixed Awl

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