FDA recall Z-0826-2019

Product

21Y14 PushValve 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.

Reason for recall

Some of the installed valve-inserts have a diameter smaller than the specification.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2019-01-10

Report date

2019-02-20

Termination date

2021-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Duderstadt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2019