Cortera Spinal Fixation System — Class II medical device recall Z-0846-2024
Ongoing recall by XTANT Medical Holdings, Inc, reported 2024-02-07. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw sha
| Recall number | Z-0846-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | XTANT Medical Holdings, Inc, Belgrade, MT, United States |
| Recall initiated | 2023-11-28 |
| Classified | 2024-01-29 |
| Reported by FDA | 2024-02-07 |
| Quantity | 6 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00810076564005 |
| Lot numbers | AP23000143 |
| Model numbers | 150100-85050 |
Product
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Reason for recall
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
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-0846-2024. 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.