Recall Z-2279-2025— SPINEART SA
Class II · Ongoing
Class II FDA medical device recall by SPINEART SA, initiated 2025-06-30. It names one FDA 510(k) clearance: K203506. 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. Reason: Cannulated fenestrated polyaxial screws may be incorrectly labeled.
- Recalling firm
- SPINEART SA
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-30
- Firm location
- Plan-Les-Ouates, N/A, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Data sourced from openFDA. This site is unofficial and independent of the FDA.