FDA-Device2016-01-13Class II
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
Otto Bock Healthcare GmbH
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.
Sold states
Nationwide Distribution.
Affected count
40 units
Manufactured in
Max-Nader-Str. #15, N/A, Duderstadt, N/A, Germany
Products
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0608-2016Don't want to check this manually?
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