Amendia, Inc: Medical Device Recall in 2016 - (Recall #: Z-0827-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Zeus-P Lumbar Interbody Device

Product Classification:

Class II

Date Initiated: November 22, 2016

Date Posted: December 28, 2016

Recall Number: Z-0827-2017

Event ID: 75855

Reason for Recall:

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.

Status: Terminated

Product Quantity: 25 units

Code Information:

Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated