Z-0827-2017Class II

Zeus-P Lumbar Interbody Device

Name: Z-0827-2017 Zeus-P Lumbar Interbody Device
Creator: Amendia, Inc
Published: 2016-11-22
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2016-11-22 / Terminated / root cause: labeling and UDI

FDA source

Amendia, Inc began a recall of Zeus-P Lumbar Interbody Device on 2016-11-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0827-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2016-12-20
Terminated: 2017-06-05
Recalling firm: Spinal Elements, Inc
Product: Zeus-P Lumbar Interbody Device
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Amendia Inc. sent an Urgent - Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. For further questions please call (404) 610-7215.
Quantity in commerce: 25 units
Distribution: US Distribution to the states of : GA. MI, OK, SC, TX, VA
Product codes and lots: Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0827-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0827-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20

Product code MAX

K151322Class IIAmendia Interbody Fusion DevicesAmendia, Inc. / cleared 2015-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)