Home / Recalls / Medical Devices
Amendia, Inc recalls Zeus-P Lumbar Interbody Device
Recalled December 28, 2016 · FDA recall Z-0827-2017 · Amendia
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. · FDA Class II
Units
25 units
Sold at
US Distribution to the states of : GA. MI, OK, SC, TX, VA
Description
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.
Product
Zeus-P Lumbar Interbody Device
Manufacturer(s)
Amendia, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →