Reported Mar 7, 2018 · Terminated
OTTO BOCK Kenevo knee joints Model 3C60=ST
Otto Bock Healthcare Product
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 Product · Brehmstrase 16 · Vienna, N/A · N/A
Is this the product you have?
- OTTO BOCK Kenevo knee joints Model 3C60=ST
- Lot codes and dates
- Serial Numbers
20152002820152002720150026and 201530040
- Serial Numbers
- Amount recalled
- 4
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cause damage to the pylon. When used longer than 1.45 million cycles (which represents approximately 2.3 years of use of the knee joint under heavy usage conditions), AND the pylon clamp is overtightened according to the labeled torque specification, AND the patient weighs at most 125kg it may be remote that the pylon breaks, and causing the patient to fall. There have been no failures or complaints reported directly attributed to the failure mode collapsed pylon . In the US Market and in Canada, labeling requires a condition based service at three years. In the rest of the world, a mandatory two year service interval is specified. Only the devices in distribution in the United States and Canada are affected by this action.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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