FDA-Device2016-12-28Class II
Zeus-P Lumbar Interbody Device
Amendia, Inc
Hazard
Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.
Sold states
US Distribution to the states of : GA. MI, OK, SC, TX, VA
Affected count
25 units
Manufactured in
1755 W Oak Pkwy, N/A, Marietta, GA, United States
Products
Zeus-P Lumbar Interbody Device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0827-2017Don't want to check this manually?
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