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U.S. Department of Health and Human Services

Class 2 Device Recall Otto Bock Modular Knee Joint,

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 Class 2 Device Recall Otto Bock Modular Knee Joint,see related information
Date Initiated by FirmOctober 28, 2008
Date PostedDecember 16, 2009
Recall Status1 Terminated 3 on December 10, 2011
Recall NumberZ-0537-2010
Recall Event ID 50486
Product Classification External Limb Knee Joint Component - Product Code ISY
ProductOtto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. Pediatric Prosthetic Device used by Lower Limb amputees.
Code Information Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.
Recalling Firm/
Manufacturer		 Bock,Otto,Orthopedic Ind,Inc
Two Carlson Parkway North, Suite 100
Minneapolis MN 55447
For Additional Information Contact
612-553-9464
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionConsignees 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 in Commerce9
DistributionThe product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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