Home / Recalls / Ottobock Orthopedic Industrie / Z-0826-2019

Z-0826-2019 Class II Terminated

Recalled by Ottobock Orthopedic Industrie — Duderstadt, N/A

Recall Details

Product Type
Devices
Report Date
February 20, 2019
Initiation Date
January 10, 2019
Termination Date
June 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
538 units

Product Description

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 Pattern

US Nationwide Distribution

Code Information

The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018

Other recalls by Ottobock Orthopedic Industrie

  • Z-0827-2019 Class II — 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is int (January 10, 2019)
  • Z-0828-2019 Class II — 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusiv (January 10, 2019)