Z-0608-2016 Class II Terminated

Recalled by Otto Bock Healthcare GmbH — Duderstadt, N/A

Recall Details

Product Type
Devices
Report Date
January 13, 2016
Initiation Date
January 4, 2016
Termination Date
May 2, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution.

Code Information

All serviced between 27 April 2015 and 17 November 2015