🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: June 30, 2025 SPINEART SA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Code: Lot number 8-4266 GTIN 07640305160493
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
SPINEART SA
Reason for Recall:
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot Code: Lot number 8-4266 GTIN 07640305160493

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2280-2025

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