Amendia, Inc recalls Zeus-P Lumbar Interbody Device

Recall date

November 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0827-2017

FDA classification

Class II

Brand / firm

Amendia, Inc

Sold / distributed

US Distribution to the states of : GA. MI, OK, SC, TX, VA

Why it was recalled

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.

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

What was recalled

Zeus-P Lumbar Interbody Device