FDA-Device2019-02-20Class II
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.
Ottobock Orthopedic Industrie
Hazard
Some of the installed valve-inserts have a diameter smaller than the specification.
Sold states
US Nationwide Distribution
Affected count
1 unit
Manufactured in
Max-Nader Str 15 D-37ns, N/A, Duderstadt, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0827-2019Don't want to check this manually?
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