Reported Jan 13, 2016 · Terminated
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of…
Otto Bock Healthcare GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Otto Bock Healthcare GmbH · Max-Nader-Str. #15 · Duderstadt, N/A · N/A
Is this the product you have?
- Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
- Lot codes and dates
- All serviced between 27 April 2015 and 17 November 2015
- Amount recalled
- 40 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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