Class 2 Device Recall PERLA TL MIS

• Date Initiated by Firm: June 30, 2025
• Date Posted: August 08, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2280-2025
• Recall Event ID: 97248
• 510(K)Number: K203506
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
• Code Information: Lot Code: Lot number 8-4266 GTIN 07640305160493
• FEI Number: 3007728266
• Recalling Firm/ Manufacturer: SPINEART SA; Chemin Du Pre-Fleuri 3; Plan-Les-Ouates Switzerland
• For Additional Information Contact: Laure-Allison Verboux; +41-22-5701281
• Manufacturer Reason for Recall: Cannulated fenestrated polyaxial screws may be incorrectly labeled
• FDA Determined 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. 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.
• Quantity in Commerce: 0
• Distribution: US Nationwide distribution in the states of Florida , Kentucky, California.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NKB