Genius Total Knee System recallZ-0833-2019 · Signature Orthopedics Pty Limited · initiated Dec 10, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Signature Orthopedics Pty Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product mix up
FDA root cause category: Mixed-up of materials/components
What the company is doing
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
Recall details
- Recall number
- Z-0833-2019
- Status
- Terminated
- Initiated by the company
- Dec 10, 2018
- Recalling firm
- Signature Orthopedics Pty Limited
- Quantity
- 10
- Product code
- JWH
- FDA submissions
- K170613
- Distribution
- US Nationwide Distribution in the states of FL, NY, and TN
Product description
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Code information (models, lots, serial numbers)
UDI # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Genius Total Knee System 121-07-4004Signature Orthopaedics Pty Ltd · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 report
Product lines
Other devices under the same FDA submission
1 device cleared under K170613 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Genius Total Knee System 121-07-3000Signature Orthopaedics Pty Ltd · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 81967).
- Z-0834-2019 · TerminatedGenius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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