The Recall Desk

Manufacturer

Ottobock Orthopedic Industrie

3 recalls in our database name Ottobock Orthopedic Industrie as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2019-02-20

Of the 3 recalls from Ottobock Orthopedic Industrie we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • ModerateFDA (Devices)·Z-0826-2019·2019-02-20

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2019·2019-02-20

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0828-2019·2019-02-20

    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
    Medical Device
    Distribution
    Distributed nationwide