Date Initiated by Firm |
August 12, 2015 |
Date Posted |
August 21, 2015 |
Recall Status1 |
Terminated 3 on October 28, 2015 |
Recall Number |
Z-2438-2015 |
Recall Event ID |
71950 |
Product Classification |
Assembly, knee/shank/ankle/foot, external - Product Code ISW
|
Product |
Otto 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 |
Action |
The 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 Commerce |
1 |
Distribution |
Distributed to the state OH. |
Total Product Life Cycle |
TPLC Device Report
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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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