Device 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.
Z-0828-2019
Product summary
- Event
- Event 81926
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110 units
- Official record key
device-enforcement:Z-0828-2019
Official wording
Reason: Some of the installed valve-inserts have a diameter smaller than the specification.
Code information: The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Some of the installed valve-inserts have a diameter smaller than the specification.