Otto Bock Genium X3 Knee Joint Prosthesis Recalled for Hydraulic Failure
Otto Bock Healthcare Products GmbH is recalling the Genium X3 knee joint prosthesis because its hydraulic resistance control may fail under certain conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (hydraulic failure) that poses a risk of harm to the user, but the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis, Model Number 3B5-2. The product is intended to be used solely for lower limb prosthetic fittings.
The recall is being issued due to issues with the resistance-control of the hydraulics, which may fail under conditions. The source text does not specify the exact conditions or the nature of the failure beyond the potential for hydraulic resistance control issues.
The recall affects one unit with Serial Number 201528049, manufactured on 01 July 2015. This specific unit was distributed to the state of Ohio. The source text does not provide information on other affected units or broader distribution patterns.
The recalled product
- Product
- Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.
- Manufacturer
- Otto Bock Healthcare Product
- Hazard
- Affected units
- 1
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 (2)
- Serial Number 201528049
- manufactured on 01 July 2015
Distribution
Distribution scope not specified by the agency.
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