🔍 RecallPedia

A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.

Class I - Dangerous
🏥 Medical Devices Recalled: September 10, 2019 Alto Development Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    327705, 327706, 330587, 330588, 330753, 334396, 345417, 345418
  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:
Alto Development Corp
Reason for Recall:
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.

Product Codes/Lot Numbers:

327705, 327706, 330587, 330588, 330753, 334396, 345417, 345418

Distribution:

Distributed in: AL, CA, FL, GA, IL, LA, MO, OK, MS, NM, SC, TX, UT, VT, WA, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0244-2020

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