FDA Medical Device Recalls (openFDA)
Signature Orthopedics Pty Limited: Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
- Recall number
- Z-0834-2019
- Recalling firm
- Signature Orthopedics Pty Limited
- Product
- Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
- Status
- Terminated
- Initiated
- 2018-12-10
- Posted
- not on file
- Terminated
- 2020-12-14
- Reason
- Product mix up
- Root cause
- 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
- 3
- Distribution
- US Nationwide Distribution in the states of FL, NY, and TN
- Lot, serial or model codes
- UDI # 09348215020330 Device Model # 121-07-3000 Lot # 788F7-1
- 510(k) numbers
- ["K170613"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3008262872
- Firm city
- West
- Firm state
- Lane Cove
- Firm country
- Australia
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28