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…

Recall date

January 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0608-2016

FDA classification

Class II

Brand / firm

Otto Bock Healthcare GmbH

Sold / distributed

Nationwide Distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.