The Recall Desk
HighFDA (Devices)·Z-0814-2018·Announced 2018-03-07

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.

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 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
Category
Medical Device — Orthopedic Prosthesis
Hazard
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

Distributed in 26 states:

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

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