Zeus-P Lumbar Interbody Device — Class II medical device recall Z-0827-2017
Terminated recall by Amendia, Inc, reported 2016-12-28, distributed in GA, MI, OK, SC, TX, VA. Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated
| Recall number | Z-0827-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amendia, Inc, Marietta, GA, United States |
| Recall initiated | 2016-11-22 |
| Classified | 2016-12-20 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-06-05 |
| Distributed | GA, MI, OK, SC, TX, VA |
| Quantity | 25 units |
| Reason classes | labeling |
| Lot numbers | 128945, 128946 |
| Model numbers | 1-110926B, 1-120922B |
Product
Zeus-P Lumbar Interbody Device
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0827-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.