FDA Device recall Z-0827-2017
Zeus-P Lumbar Interbody Device
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Zeus-P Lumbar Interbody Device by Amendia, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0827-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-22 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amendia |
| Distribution | GA, MI, OK, SC, TX, VA |
Product
Zeus-P Lumbar Interbody Device
Reason
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.
Identifiers
| code_info | Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0827-2017%22
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