The Recall Desk

Manufacturer

Otto Bock Healthcare GmbH

3 recalls in our database name Otto Bock Healthcare GmbH as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2016-01-13

Of the 3 recalls from Otto Bock Healthcare GmbH 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-0608-2016·2016-01-13

    Otto Bock Recalls Modular Polycentric EBS Knee Joints Due to Service Error

    Otto Bock is recalling 40 Modular Polycentric EBS Knee Joints serviced between April 2015 and November 2015 because the wrong Loctite was used during repair.

    Product
    Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2016·2015-11-11

    Otto Bock Triton Smart Ankle Recalled Due to Software Issue

    Otto Bock is recalling the Triton Smart Ankle and iOS Galileo app due to a software issue that can cause unexpected foot movement, posing a fall risk.

    Product
    iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2261-2015·2015-08-05

    Otto Bock Recalls Pheon 3R62 Polycentric Prosthetic Knee Joints

    Otto Bock Healthcare GmbH is voluntarily recalling 3R62 Pheon prosthetic knee joints because the locking function may fail, potentially causing a fall.

    Product
    Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide