Recall Z-0814-2018 ยท ISY Joint, Knee, External Limb Component
Otto Bock Healthcare Product
OTTO BOCK Kenevo knee joints Model 3C60
| Date | Sep 12, 2017 |
| Status | Terminated |
| 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 fail |
| 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.