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U.S. Department of Health and Human Services

Class 2 Device Recall Otto Bock 3R90 and 3R92 Single Axis Knee Joint

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 Class 2 Device Recall Otto Bock 3R90 and 3R92 Single Axis Knee Jointsee related information
Date Initiated by FirmJuly 15, 2004
Date PostedAugust 18, 2004
Recall Status1 Terminated 3 on November 07, 2005
Recall NumberZ-1379-04
Recall Event ID 29670
Product Classification Component, External, Limb, Ankle/Foot - Product Code ISH
ProductModular Knee Joint with Friction Brake
Code Information No lot numbers are used. Recall covers patients who were fit with either of the products between March 1, 2004 and July 9, 2004.
Recalling Firm/
Manufacturer		 Bock,Otto,Orthopedic Ind,Inc
3000 Xenium Ln N
Minneapolis MN 55441-2661
For Additional Information ContactStephen A. Carr
763-489-5106
Manufacturer Reason
for Recall		Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the braking performance of the knee to malfunction.
FDA Determined
Cause 2		Other
ActionThe braking plate of the knee may become dislodged, which may cause the braking performance of the knee to malfunction.
Quantity in Commerce457 devices
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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