Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Softw
FDA device recall Z-2279-2025 · posted 2025-08-08 · Open, Classified
Recall details
- Recalling firm
- SPINEART SA
- Reason for recall
- Cannulated fenestrated polyaxial screws may be incorrectly labeled
- Action taken
- 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. 23332 Mill Creek Drive Suite 150 Laguna Hills, CA. 92653 (3) You may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document. (4) Surgeons/physicians should closely monitor patients that have been implanted with these potential non-conforming screws.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 16 units
- Distribution
- US Nationwide distribution in the states of Florida , Kentucky, California.
- Date initiated
- 2025-06-30
- Date posted
- 2025-08-08
- Location
- Plan-Les-Ouates, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERLA® TL posterior osteosynthesis system (K203506) | Spineart | 2021-01-15 |