Recall Z-2279-2025 · NKB Thoracolumbosacral Pedicle Screw System
SPINEART SA
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
| Date | Aug 8, 2025 (initiated Jun 30, 2025) |
| Status | Open, Classified |
| Reason | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| Root cause | Labeling Change Control |
| Action | On July 4, 2025, Spineart SA, issued a Urgent: Medical Device Recall Notification to affected consignees via E-Mail. On July 10, 2025, Spineart SA issued a revised notification to provide additional information. On July 16,2025, Spineart expanded the recall to include an additional product and lot. Spineart SA ask consignees to take the following steps: (1) Please acknowledge receipt of this letter by emailing to orders@spineart.us (2) Please discontinue use and return any product on hand that is listed in the Product and Distribution Information section of this letter to: Spineart U.S.A |
| Quantity | 16 units |
| Distribution | US Nationwide distribution in the states of Florida , Kentucky, California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203506 | PERLA® TL posterior osteosynthesis system Spineart, Jan 15, 2021 |