Recall Z-2279-2025
Spineart SA · initiated June 30, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Code: Lot number 8-4528 GTIN 07640305160561
Reason for recall
Cannulated fenestrated polyaxial screws may be incorrectly labeled
FDA-determined cause: Labeling Change Control
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.
Details
- Recall number
- Z-2279-2025
- Initiated
- June 30, 2025
- Posted by FDA
- August 8, 2025
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 16 units
- Distribution
- US Nationwide distribution in the states of Florida , Kentucky, California.
- Recalling firm
- Spineart SA, Plan-Les-Ouates
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2280-2025 Class II | Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW…Cannulated fenestrated polyaxial screws may be incorrectly labeled | 06/30/2025Open, Classified |