Otto Bock Healthcare GmbH: Medical Device Recall in 2016 - (Recall #: Z-0608-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 4, 2016

Date Posted: January 13, 2016

Recall Number: Z-0608-2016

Event ID: 72960

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.

Status: Terminated

Product Quantity: 40 units

Code Information:

All serviced between 27 April 2015 and 17 November 2015

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated