Z-0834-2019Class II

Genius Knee Cemented CR Femoral Component

Name: Z-0834-2019 Genius Knee Cemented CR Femoral Component
Creator: Signature Orthopedics Pty Limited
Published: 2018-12-10
License: https://open.fda.gov/license/

Signature Orthopaedics Pty Limited / initiated 2018-12-10 / Terminated

FDA source

Signature Orthopedics Pty Limited began a recall of Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component on 2018-12-10. FDA classified it as Class II and gives the reason as "Product mix up". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0834-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-10
Posted: 2019-02-14
Terminated: 2020-12-14
Recalling firm: Signature Orthopaedics Pty Limited
Product: Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Product mix up
FDA 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: [email protected] Phone: 02 9428 5181 Fax: 02 8456 6065
Quantity in commerce: 3
Distribution: US Nationwide Distribution in the states of FL, NY, and TN
Product codes and lots: UDI # 09348215020330 Device Model # 121-07-3000 Lot # 788F7-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0834-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0833-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0834-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-14

Product code JWH

K170613Class IIGenius Total Knee SystemSignature Orthopaedics Pty, Ltd. / cleared 2017-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)