Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED… — Class II medical device recall Z-2280-2025
Ongoing recall by SPINEART SA, reported 2025-08-20, distributed nationwide. Cannulated fenestrated polyaxial screws may be incorrectly labeled
| Recall number | Z-2280-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SPINEART SA, Plan-Les-Ouates, N/A, Switzerland |
| Recall initiated | 2025-06-30 |
| Classified | 2025-08-08 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 0 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07640305160493 |
| Lot numbers | 8-4266 |
| Model numbers | 45-S |
Product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
Reason for recall
Cannulated fenestrated polyaxial screws may be incorrectly labeled
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-2280-2025. 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.