Otto Bock Kenevo Knee Joints Model 3C60=ST: Pylon Breakage Risk After 2.3 Years of Use
Recall for Otto Bock Kenevo knee joints Model 3C60=ST where pylon may break after 2.3 years of heavy use, risking falls. Affected units sold in US/Canada with specific serial numbers.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Otto Bock is recalling certain Kenevo knee joints (Model 3C60=ST) because the pylon could break after about 2.3 years of heavy use, potentially causing falls. This risk is specific to units sold in the US and Canada with certain serial numbers. Read more at govinfonow.com/recall/73032-otto-bock-kenevo-knee-joints-model-3c60-st-pylon-breakage.
Source Summary by GovInfoNow · govinfonow.com/recall/73032-otto-bock-kenevo-knee-joints-model-3c60-st-pylon-breakage · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0815-2018
Cite this page
“Otto Bock Kenevo Knee Joints Model 3C60=ST: Pylon Breakage Risk After 2.3 Years of Use.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73032-otto-bock-kenevo-knee-joints-model-3c60-st-pylon-breakage. Based on FDA recall #Z-0815-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0815-2018%22&limit=1).
Why it’s dangerous
The pylon clamping mechanism may break after about 2.3 years of heavy use if the patient weighs 125kg or less and the clamp is overtightened to the labeled torque. This could cause the patient to fall if the pylon breaks.
Who’s affected
People with Otto Bock Kenevo knee joints Model 3C60=ST in the US and Canada who have used them for more than 2.3 years under heavy conditions are at risk. Patients weighing over 125kg are not affected by this issue.
How to tell if you have this one
Check for serial numbers: 201520028, 201520027, 20150026, and 201530040. Only units sold in the US and Canada are affected by this recall.
- Brand
Otto Bock- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0814-2018 | OTTO BOCK Kenevo knee joints Model 3C60; 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. | 75 units |
| Z-0815-2018 | OTTO BOCK Kenevo knee joints Model 3C60=ST; Serial Numbers: 201520028, 201520027, 20150026, and 201530040, | 4 |
What to do — step by step
Check Serial Number
Look for the specific serial numbers listed in the recall: 201520028, 201520027, 20150026, and 201530040.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0815-2018 (September 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0815-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.