Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 7, 2018
OTTO BOCK Kenevo knee joints Model 3C60
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Otto Bock Healthcare Product recalled OTTO BOCK Kenevo knee joints Model 3C60 - a moderate-severity action.
OTTO BOCK Kenevo knee joints Model 3C60 was recalled by Otto Bock Healthcare Product in March 7, 2018. Reason: Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where t…. Check the official notice for the remedy. Verify recall #Z-0814-2018 with the FDA Devices before acting.
The recall
Otto Bock Healthcare Product issued this moderate-severity FDA Devices recall-Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where t….
- Moderate
- severity level
- 75 units
- affected scope
- Class II
- classification
- March 7, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0814-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0814-2018) was formally reported on March 7, 2018, with the manufacturer initiating the action on September 12, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Otto Bock Healthcare Product is listed as the recalling firm, operating out of Vienna, N/A. Federal records list the affected scope as 75 units.
The documented reason for this recall is: 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 millio… Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
75 units
Related Recalls
6
3 from same agency
Product description
OTTO BOCK Kenevo knee joints Model 3C60
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0814-2018 |
| Date reported | March 7, 2018 |
| Date initiated | September 12, 2017 |
| Recalling firm | Otto Bock Healthcare Product |
| Firm location | Vienna, N/A |
| Affected scope | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0814-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
OTTO BOCK Kenevo knee joints Model 3C60. Recalled by Otto Bock Healthcare Product. Units affected: 75 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0814-2018.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0814-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 7, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.