Lane Cove West, N/A, Australia
Signature Orthopedics Pty Limited recalls
3 recalls recorded since 2018, most recently on 20 April 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 20 April 2021
- Terminated
- 19 January 2023
- Reason
- Product mislabeled, with the incorrect product inside the package.
- Distribution
- US Nationwide distribution in the state of NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1694-2021
- Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Terminated Class II Medical devices
- Recall started
- 10 December 2018
- Terminated
- 14 December 2020
- Reason
- Product mix up
- Distribution
- US Nationwide Distribution in the states of FL, NY, and TN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0833-2019, Z-0834-2019
- Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
- Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Terminated Class II Medical devices
- Recall started
- 2 February 2018
- Terminated
- 8 August 2018
- Reason
- This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.
- Distribution
- Worldwide Distribution - U.S. Nationwide and the country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0920-2018
- Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.