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U.S. Department of Health and Human Services

Class 2 Device Recall Genium X3

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 Class 2 Device Recall Genium X3see related information
Date Initiated by FirmAugust 12, 2015
Date PostedAugust 21, 2015
Recall Status1 Terminated 3 on October 28, 2015
Recall NumberZ-2438-2015
Recall Event ID 71950
Product Classification Assembly, knee/shank/ankle/foot, external - Product Code ISW
ProductOtto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.
Code Information Serial Number 201528049, manufactured on 01 July 2015
Recalling Firm/
Manufacturer		 Otto Bock Healthcare Product
Brehmstrasse 16
Wien Austria
Manufacturer Reason
for Recall		Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.
FDA Determined
Cause 2		Process control
ActionThe consignee was notified via e-mail and telephone on 12 August 2015. The affected product was identified, as well as the reason for the recall. The firm will replace the affected device with a new one. A return authorization and label will be provided for the recalled product to be returned as soon as possible.
Quantity in Commerce1
DistributionDistributed to the state OH.
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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