FDA Recall
Terminated
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
Recall: Z-0608-2016
·
Initiated January 4, 2016
Recall
- Recall Number
- Z-0608-2016
- Event Number
- 72960
- Firm
- Otto Bock Healthcare GmbH Max-Nader-Str. # 15 Duderstadt Germany
- FEI Number
- 3003117657
- Product Code
- ISY
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 4, 2016
- Terminated
- May 2, 2016
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
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.
Action
Starting Jan 4 2016, In coordination with the Manufacturer, the US Agent will notify customers via telephone call of the correction on behalf of the Manufacturer. The customers will be requested to return the affected devices back to the service center for correction. The devices will be returned to the customer following correction.
Distribution
Nationwide Distribution.
Quantity
40 units