Z-0814-2018Class II

OTTO BOCK Kenevo knee joints Model 3C60

Name: Z-0814-2018 OTTO BOCK Kenevo knee joints Model 3C60
Creator: Otto Bock Healthcare Product
Published: 2017-09-12
License: https://open.fda.gov/license/

Otto Bock Healthcare Products GmbH / initiated 2017-09-12 / Terminated / root cause: design

FDA source

Otto Bock Healthcare Product began a recall of OTTO BOCK Kenevo knee joints Model 3C60 on 2017-09-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0814-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-12
Posted: 2018-03-01
Terminated: 2021-01-19
Recalling firm: Otto Bock Healthcare Products GmbH
Product: OTTO BOCK Kenevo knee joints Model 3C60
Product code: ISY Joint, Knee, External Limb Component
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.
Root cause tag: design
FDA root cause: Device Design
Action: On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service. Customer Service: (800) 328-3458 Option 1 Loaner Service: (800) 328-3458 Option 3, then Option 1
Quantity in commerce: 75 units
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0814-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0814-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01
Z-0815-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code ISY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)