Z-0608-2016 Class II Terminated
FDA device recall Z-0608-2016 was initiated by Otto Bock Healthcare GmbH on January 4, 2016 and is designated Class II. 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 … The recall status is terminated (terminated May 2, 2016). Affected quantity: 40 units.
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