# FDA recall Z-0815-2018

> **Otto Bock Healthcare Product** · Class II · device recall initiated 2017-09-12.

## Product

OTTO BOCK Kenevo knee joints Model 3C60=ST

## Reason for recall

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.

## Distribution

AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA  AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU

## Key facts

- **Recall number:** Z-0815-2018
- **Recalling firm:** Otto Bock Healthcare Product
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-12
- **Report date:** 2018-03-07
- **Termination date:** 2021-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vienna, N/A, Austria

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0815-2018

## Citation

> AI Analytics. FDA recall Z-0815-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0815-2018. Source: US FDA. Licensed CC0.

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