Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Zeus-P Lumbar Interbody Device Recalled by Amendia, Inc Due to Labeling error where three boxes in inventory had...

Date: November 22, 2016
Company: Amendia, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amendia, Inc directly.

Affected Products

Zeus-P Lumbar Interbody Device

Quantity: 25 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 6 states: GA, MI, OK, SC, TX, VA

Affected (6 states)Not affected

About Amendia, Inc

Amendia, Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report