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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Ottobock Orthopedic Industrie: Some of the installed valve-inserts have a diameter smaller than the specification.

Agency Publication Date: February 13, 2019
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Affected Products

Product: 21Y14 PushValve 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.

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

Product: 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.

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

Product: 21Y15 MagValve 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.

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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81926
Status: Resolved
Manufacturer: Ottobock Orthopedic Industrie
Manufactured In: Germany
Units Affected: 3 products (538 units; 1 unit; 110 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.