The Recall Desk

FDA (Devices) recall action 81926

Ottobock Orthopedic Industrie recalled 3 products on 2019-02-20

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-02-20
Critical
0
Units
649

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2019-02-20

    Ottobock PushValve Recall for Diameter Specification Defect

    Ottobock is recalling 538 PushValve units because some valve inserts have a diameter smaller than the specification. The valve is used for prosthetic fitting of lower limb amputees.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-02-20

    Ottobock PushValve Upper Part Recalled for Diameter Specification Defect

    Ottobock is recalling PushValve upper parts because some installed valve inserts have a diameter smaller than the specification.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-02-20

    Ottobock MagValve Recall for Prosthetic Socket Air Evacuation Defect

    Ottobock is recalling 110 MagValve units used in prosthetic sockets because some valve inserts have a smaller diameter than specified.

    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.
    Category
    Distribution
    0 states