Date Initiated by Firm |
December 10, 2018 |
Create Date |
February 14, 2019 |
Recall Status1 |
Terminated 3 on December 14, 2020 |
Recall Number |
Z-0834-2019 |
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 CR Femoral Component
Product Usage: Knee replacement component
|
Code Information |
UDI # 09348215020330 Device Model # 121-07-3000 Lot # 788F7-1 |
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 |
3 |
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.
|