Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED Recalled by SPINEART SA Due to Cannulated fenestrated polyaxial screws may be incorrectly labeled

Date: June 30, 2025
Company: SPINEART SA
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SPINEART SA directly.

Affected Products

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

Quantity: 0

Why Was This Recalled?

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SPINEART SA

SPINEART SA has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report