🔍 RecallPedia

TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

Class I - Dangerous
🏥 Medical Devices Recalled: January 25, 2023 Limacorporate S.p.A Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241
  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:
Limacorporate S.p.A
Reason for Recall:
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

Product Codes/Lot Numbers:

Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241

Distribution:

Distributed in: TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1261-2023

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