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.
FDA Recall Z-0537-2010 · Posted 2009-12-16
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Recalling FirmBock,Otto,Orthopedic Ind,Inc
Recall StatusTerminated
Product CodeISY
Date Initiated2008-10-28
Date Terminated2011-12-10
Product Quantity9
Reason for Recall
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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