SPINEART SA: Medical Device Recall in 2025 - (Recall #: Z-2279-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product 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

Product Classification:

Class II

Date Initiated: June 30, 2025

Date Posted: August 20, 2025

Recall Number: Z-2279-2025

Event ID: 97248

Reason for Recall:

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Status: Ongoing

Product Quantity: 16 units

Code Information:

Lot Code: Lot number 8-4528 GTIN 07640305160561

Distribution Pattern:

US Nationwide distribution in the states of Florida , Kentucky, California.

Voluntary or Mandated:

Voluntary: Firm initiated