Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Recall
- Recall Number
- Z-0833-2019
- Event Number
- 81967
- FEI Number
- 3008262872
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- December 10, 2018
- Terminated
- December 14, 2020
- Address
- Signature Orthopedics Pty Limited Lane Cove W 7 Sirius Rd Lane Cove West Australia
Description
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Product mix up
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: [email protected] Phone: 02 9428 5181 Fax: 02 8456 6065
US Nationwide Distribution in the states of FL, NY, and TN
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