Class II — SPINEART SA
| Recalling firm | SPINEART SA |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| Product | Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No |
| Quantity | 16 units |
| Distribution | US Nationwide distribution in the states of Florida , Kentucky, California. |
| Initiated | 2025-06-30 |
| Classified | 2025-08-08 |
| Recall number | Z-2279-2025 |
| 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 — SPINEART SA (Z-2279-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97248/
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