FDA Device recall Z-0814-2018
OTTO BOCK Kenevo knee joints Model 3C60
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of OTTO BOCK Kenevo knee joints Model 3C60 by Otto Bock Healthcare Product, citing 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 py….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0814-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-12 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Otto Bock Healthcare Product |
| Distribution | AK, AR, AZ, CA, CT, DC, DE, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, NY, OH, OK, OR, PA, PR, TX, VA, WA |
Product
OTTO BOCK Kenevo knee joints Model 3C60
Reason
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.
Identifiers
| code_info | Serial Numbers: 201520007, 201520010, 201520012, 201520008, 201520009, 201522040, 201520002, 201520011, 201520006, 2…Serial Numbers: 201520007, 201520010, 201520012, 201520008, 201520009, 201522040, 201520002, 201520011, 201520006, 201522046, 201522043, 201520028, 201528134, 201528139, 201520013, 201522045, 201525069, 201525109, 201524051, 201524050, 201549087, 201550012, 201550020, 201550022, 201550017, 201550028, 201550027, 201550016, 201550036, 201550014, 201551005, 201550025, 201551028, 201551030, 201550040, 201551032, 201602031, 201602030, 201603014, 201603016, 201603023, 201602034, 201602036, 201602032, 201551034, 201603029, 201603027, 201603028, 201610008, 201601018, 201610010, 201610015, 201610019, 201610022, 201610020, 201611001, 201611010, 201520027, 201610030, 201610035, 201611012, 201603025, 201611002, 201611018, 201612018, 201612020, 201613021, 201613019, 201615008, 201618017, 201616010, 201613008, 201616004, 201616005, 201616012, 201618023, 201618021, 201618018, 201618019, 201618024, 201617031, and 201618025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0814-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.