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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