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Recall Observatory FDA recall evidence

Device 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.

Z-0608-2016

January 04, 2016

Class II

Product summary

Firm
Otto Bock Healthcare GmbH
Event
Event 72960
Status
Terminated
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-0608-2016

Official wording

Reason: 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.

Code information: All serviced between 27 April 2015 and 17 November 2015

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.