FDA-Device2016-12-28Class II
Optimus Fixed Awl
Amendia, Inc
Hazard
Complaints that the tip of the awl broke after impaction during surgery.
Sold states
US Distribution to the states of : FL, GA. IL, MO, TX
Affected count
9 devices
Manufactured in
1755 W Oak Pkwy, N/A, Marietta, GA, United States
Products
Optimus Fixed Awl
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0891-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief