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U.S. Department of Health and Human Services

Class 2 Device Recall Genius Total Knee System

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  Class 2 Device Recall Genius Total Knee System see related information
Date Initiated by Firm December 10, 2018
Create Date February 14, 2019
Recall Status1 Terminated 3 on December 14, 2020
Recall Number Z-0833-2019
Recall Event ID 81967
510(K)Number K170613  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Genius Knee Cemented Tibial Component

Product Usage:
Knee replacement component
Code Information UDI # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F 
Recalling Firm/
Manufacturer		 Signature Orthopedics Pty Limited
Lane Cove W
7 Sirius Rd
Lane Cove West Australia
Manufacturer Reason
for Recall		 Product mix up
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On 12/10/2018 the firm sent letters to their customer informing them of the recall and asked the customers to Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall by forwarding this letter. Please complete the attached Customer Acknowledgement Form and fax or email it to us so that we may arrange for your stock to be recovered and replacement stock, or a credit note, issued. Please complete the Customer Acknowledgement Form even if you have no stock which is subject to recall, as we require this information to reconcile this process. Please complete this action within 2 weeks of the date on this letter to ensure the correction is implemented expeditiously. This recall should be carried out to the hospital level. Your assistance is appreciated and necessary to prevent delay in surgery. For further information, please make contact via the details provided below. Signature Orthopaedics Pty Ltd sincerely regrets any inconvenience caused. Christian Wight Regulatory Affairs Manager Signature Orthopaedics Pty Ltd 7 Sirius Road Lane Cove West, NSW 2066 Australia Email: christian@signatureortho.com.au Phone: 02 9428 5181 Fax: 02 8456 6065
Quantity in Commerce 10
Distribution US Nationwide Distribution in the states of FL, NY, and TN
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = Signature Orthopaedics Pty Ltd.
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