Reported Aug 20, 2025 · Ongoing

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S…

Spineart Sa

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SPINEART SA · Chemin Du Pre-Fleuri 3 · Plan-Les-Ouates, N/A · N/A

Is this the product you have?

  • Brand NamePERLA ¿
  • TL MIS Product NameCANNULATED FENESTRATED
  • POLYAXIAL SCREW Model/Catalog NumberMPF-PS 55 45-S
  • Software VersionNot
  • Applicable Product DescriptionCANNULATED FENESTRATED POLYAXIAL SCREW
Lot codes and dates
  • Lot CodeLot number 8-4266 GTIN 07640305160493
Amount recalled
0

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Cannulated fenestrated polyaxial screws may be incorrectly labeled

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.