Otto Bock Kenevo Knee Joints Recalled for Pylon Breakage Risk
Otto Bock is recalling 75 Kenevo knee joints due to a design issue that could cause the pylon to break under specific heavy-use conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 criteria for a High severity score.
Plain-English summary
Otto Bock Healthcare Products GmbH is recalling 75 units of the OTTO BOCK Kenevo knee joints Model 3C60. The recall was initiated after extended durability testing identified a design issue with the pylon clamping mechanism. This mechanism has the potential to cause damage to the pylon, which could lead to the pylon breaking and causing the patient to fall.
The risk of failure is specific to devices used longer than 1.45 million cycles (approximately 2.3 years under heavy usage conditions) where the pylon clamp is overtightened according to the labeled torque specification and the patient weighs at most 125kg. The company states that 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. In these markets, labeling requires a condition-based service at three years, whereas a mandatory two-year service interval is specified in the rest of the world. Consumers should contact Otto Bock Healthcare Products for instructions on how to proceed with the recall.
The recalled product
- Product
- OTTO BOCK Kenevo knee joints Model 3C60
- Manufacturer
- Otto Bock Healthcare Product
- Affected units
- 75
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 (20)
- Serial Numbers: 201520007
- 201520010
- 201520012
- 201520008
- 201520009
- 201522040
- 201520002
- 201520011
- 201520006
- 201522046
- 201522043
- 201520028
- 201528134
- 201528139
- 201520013
- 201522045
- 201525069
- 201525109
- 201524051
- 201524050
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
- HighOtto Bock Genium X3 Knee Joint Prosthesis Recalled for Hydraulic Failure
FDA (Devices) · 2015-09-02
Same hazard · structural failure
See all →- High
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