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
Recall
- Recall Number
- Z-2279-2025
- Event Number
- 97248
- Firm
- SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland
- FEI Number
- 3007728266
- Product Code
- NKB
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- June 30, 2025
- Posted
- August 8, 2025
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
Cannulated fenestrated polyaxial screws may be incorrectly labeled
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 [email protected] (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.
US Nationwide distribution in the states of Florida , Kentucky, California.
16 units