FDAFDA · Food and drugs·Recall number Z-0828-2019
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.
Published February 20, 2019 · Recall initiated: January 10, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some of the installed valve-inserts have a diameter smaller than the specification.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Ottobock Orthopedic Industrie
- Distributor
- US Nationwide Distribution
- Lot
- The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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