Class II — XTANT Medical Holdings, Inc
| Recalling firm | Xtant Medical Holdings, Inc. |
|---|---|
| Registered facility | Xtant Medical Holdings, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length. |
| Quantity | 6 |
| Distribution | US distribution in MI. |
| Initiated | 2023-11-28 |
| Classified | 2024-01-29 |
| Recall number | Z-0846-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — XTANT Medical Holdings, Inc (Z-0846-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93738/
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