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U.S. Department of Health and Human Services

Class 2 Device Recall Otto Bock Compact prosthetic knee joint

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 Class 2 Device Recall Otto Bock Compact prosthetic knee jointsee related information
Date Initiated by FirmAugust 10, 2006
Date PostedJanuary 25, 2007
Recall Status1 Terminated 3 on November 26, 2008
Recall NumberZ-0363-2007
Recall Event ID 36256
510(K)NumberK991590 
Product Classification external leg prosthesis - Product Code KFX
ProductElectronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.
Code Information Material number 3C85, serial numbers: 200547006, 200547007, 200547008, 200547009, 200547034, 200547035, 200547036, 200547037, 200547038, 200547039, 200548022, 200548023, 200548037, 200548038, 200548039, 200548040, 200548041, 200548042, 200604015, 200604016, 200604017, 200604021, 200604022, 200604024, 200604064, 200605002, 200613003.   Material number 3C95, serial numbers: 200531057, 200531058, 200531059, 200531060, 200547003, 200547004, 200547005, 200547024, 200547049, 200547050, 200547051, 200547052, 200547053, 200547054, 200547055, 200547056, 200547057, 200548007, 200548008, 200548009, 200548010, 200548011, 200548012, 200548013, 200548014, 200548015, 200548016, 200548017, 200548018, 200548019, 200548020, 200548034, 200548035, 200548036, 200548044, 200548045, 200548046, 200548047, 200548048, 200548049, 200548051, 200548052, 200548053, 200548054, 200548055, 200548056, 200548058, 200548059, 200548060, 200548061, 200548062, 200548063, 200548064, 200548065, 200548067, 200548068, 200604001, 200604002, 200604003, 200604004, 200604005, 200604006, 200604007, 200604008, 200604009, 200604010, 200604012, 200604013, 200604014, 200604026, 200604027, 200604028, 200604029, 200604030, 200604032, 200604033, 200604034, 200604035, 200604036, 200604038, 200604039, 200604040, 200604041, 200604042, 200604043, 200604044, 200604045, 200604053, 200604054, 200604055, 200604056, 200604057, 200604058, 200604059, 200604062, 200604063, 200605003, 200605004, 200605005, 200605006, 200605008, 200605009, 200605010, 200605018, 200605019, 200605020, 200605021, 200605022, 200605023, 200605054, 200605055, 200605057, 200605058, 200605059, 200605060, 200605061, 200612015, 200612016, 200612017, 200612018, 200612019, 200612020, 200612021, 200612024, 200612029, 200612045, 200612047, 200612050, 200612051, 200612052, 200612053, 200612054, 200612056, 200613034, 200613035, 200613038, 200613039, 200613041, 200613042, 200613043, 200613044, 200613045, 200613054, 200613055, 200613056, 200613057, 200613061, 200613062, 200613063.
Recalling Firm/
Manufacturer
Bock,Otto,Orthopedic Ind,Inc
Two Carlson Parkway North, Suite 100
Minneapolis MN 55447
Manufacturer Reason
for Recall
A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer.
FDA Determined
Cause 2
Other
ActionAn Urgent Correction Notice, dated August 11, 2006, was sent to customers who purchased the Compact Prosthetic knee joint. The letter identifies affected units, asks for all in stock devices to be returned to Otto Bock, and for patients fitted with an affected device, a loaner knee will be provided as a temporary replacement while their device is serviced.
Quantity in Commerce176
DistributionNationwide.
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.
510(K) Database510(K)s with Product Code = KFX
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