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U.S. Department of Health and Human Services

Class 2 Device Recall Rheo Knee

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  Class 2 Device Recall Rheo Knee see related information
Date Initiated by Firm February 26, 2015
Date Posted March 25, 2015
Recall Status1 Terminated 3 on November 20, 2015
Recall Number Z-1322-2015
Recall Event ID 70693
Product Classification Assembly, knee/shank/ankle/foot, external - Product Code ISW
Product The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
Code Information Rheo 2 Item Number: RKN120007  Serial #s affected:  323056 321498
Recalling Firm/
Manufacturer		 Ossur H / F
Grjothals 5
Reykjavik Iceland
Manufacturer Reason
for Recall		 The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.
FDA Determined
Cause 2		 Employee error
Action The firm, Ossur, notified their customers of the Recall Notice via phone on February 26, 2015. The firm informed the customers about the recalled product, the problem and actions to be taken. The customers were instructed to send the unit in for service so the Acceptance testing can be performed for the unit in accordance to their process. If you have any questions, please contact Regulatory Affairs & Quality Assurance specialist at 949-382-3741 or email: kmontes@ossur.com.
Quantity in Commerce 4715 units (2 units affected)
Distribution Worldwide distribution: US distribution in TN and country of: Austria.
Total Product Life Cycle TPLC 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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