Recall Z-0608-2016— Otto Bock Healthcare GmbH
Class II · Terminated
Class II FDA medical device recall by Otto Bock Healthcare GmbH, initiated 2016-01-04, terminated 2016-05-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Otto Bock Healthcare GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-04
- Terminated
- 2016-05-02
- Firm location
- Duderstadt, N/A, Germany
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.