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Otto Bock Healthcare Recalls
3 recalls on record · August 5, 2015 to January 13, 2016 · Medical Devices
Recalls by year
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 13, 2016Medical DevicesFDA
Otto Bock Healthcare GmbH recalls Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputat
Hazard: Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair.
November 11, 2015Medical DevicesFDA
Otto Bock Healthcare GmbH recalls iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an externa
Hazard: A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Function to move the footplate towards the ground. When operating machines with foot pedals (e.g. a car) the foot could get stuck under the foot pedal and block it or, with the foot on the pedal, it could cause unintended vehicle acceleration.
August 5, 2015Medical DevicesFDA
Otto Bock Healthcare GmbH recalls Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for l
Hazard: Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall.