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Ottobock Orthopedic Industrie recalls 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower
Recalled February 20, 2019 · FDA recall Z-0828-2019 · Ottobock Orthopedic Industrie
Hazard
Some of the installed valve-inserts have a diameter smaller than the specification. · FDA Class II
Units
110 units
Sold at
US Nationwide Distribution
Description
Some of the installed valve-inserts have a diameter smaller than the specification.
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.
Manufacturer(s)
Ottobock Orthopedic Industrie
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →