Recall Z-0537-2010 ยท ISY Joint, Knee, External Limb Component
Bock,Otto,Orthopedic Ind,Inc
Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. Pediatric Prosthetic Device used by Lower Limb amputees.
| Date | Dec 16, 2009 (initiated Oct 28, 2008) |
| Status | Terminated |
| Reason | Otto Bock Health Care LP has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. This can cause the axes to gradually move out of the joint and result in a risk of falling for the user. |
| Root cause | Employee error |
| Action | Consignees were sent on 10/28/08 a Otto Bock "Urgent: Correction Notice" letter dated October 27, 2008. The letter described the product and problem. It provided instructions if the product was in stock and instructed the consignee to contact the patients (a patient letter was provided) and to complete and return the reply card. Consignees were to contact Otto Bock at their Customer Service to request a return authorization. |
| Quantity | 9 |
| Distribution | The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.