Otto Bock Kenevo Knee Joints Recalled for Pylon Breakage Risk
Otto Bock is recalling four Kenevo knee joints due to a design issue that could cause the pylon to break, leading to a fall.
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 risk-of-harm product (fall risk) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Otto Bock Healthcare Products GmbH is recalling four units of the OTTO BOCK Kenevo knee joints Model 3C60=ST. The recall is due to a design issue identified through extended durability testing where the pylon clamping mechanism has the potential to cause damage to the pylon.
The pylon may break if the device is used longer than 1.45 million cycles (approximately 2.3 years under heavy usage), the pylon clamp is overtightened, and the patient weighs at most 125kg. A broken pylon could cause the patient to fall. There have been no failures or complaints reported directly attributed to this failure mode.
The affected devices are distributed in the United States and Canada. Consumers should contact Otto Bock Healthcare Products for further instructions on how to proceed with the recall.
The recalled product
- Product
- OTTO BOCK Kenevo knee joints Model 3C60=ST
- Manufacturer
- Otto Bock Healthcare Product
- Category
- Medical Device — Orthopedic
- Affected units
- 4
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 (4)
- Serial Numbers: 201520028
- 201520027
- 20150026
- and 201530040
Distribution
Part of a larger recall action
This product is one of 2 recalled by Otto Bock Healthcare Product under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Otto Bock Healthcare Product
See all →- HighOtto Bock Kenevo Knee Joints Recalled for Pylon Breakage Risk
FDA (Devices) · 2018-03-07
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