FDAFDA · Food and drugs·Recall number Z-0608-2016
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
Published January 13, 2016 · Recall initiated: January 4, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Otto Bock Healthcare GmbH
- Distributor
- Nationwide Distribution.
- Lot
- All serviced between 27 April 2015 and 17 November 2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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