Otto Bock Recalls Modular Polycentric EBS Knee Joints Due to Service Error
Otto Bock is recalling 40 Modular Polycentric EBS Knee Joints serviced between April 2015 and November 2015 because the wrong Loctite was used during repair.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any injuries, illnesses, or hospitalizations, and the hazard is a service error (wrong adhesive) rather than a high-risk pathogen or structural defect causing immediate harm. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Otto Bock HealthCare GmbH is recalling 40 units of the Modular Polycentric EBS Knee Joint (models 3R60, 3R60=ST, 3R60=KD, and 3R60=HD). These devices are used for the prosthetic fitting of lower limb amputations.
The recall was initiated due to a service error where the wrong Loctite was used during repair. The affected units were serviced between 27 April 2015 and 17 November 2015. The products were distributed nationwide.
The source text does not specify the immediate actions consumers or healthcare providers should take, nor does it report any injuries or illnesses associated with this service error.
The recalled product
- Product
- Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
- Manufacturer
- Otto Bock Healthcare GmbH
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serviced between 27 April 2015 and 17 November 2015
Distribution
Distributed nationwide across the United States.
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