Ottobock Orthopedic Industrie recalls 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fittin…
- Recall date
- January 10, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0827-2019
- FDA classification
- Class II
- Brand / firm
- Ottobock Orthopedic Industrie
- Sold / distributed
- US Nationwide Distribution
Why it was recalled
Some of the installed valve-inserts have a diameter smaller than the specification.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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