🔍 RecallPedia

21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.

Class I - Dangerous
🏥 Medical Devices Recalled: January 10, 2019 Ottobock Orthopedic Industrie Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
  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:
Ottobock Orthopedic Industrie
Reason for Recall:
Some of the installed valve-inserts have a diameter smaller than the specification.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.

Product Codes/Lot Numbers:

The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0827-2019

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