Recall Z-0833-2019— Signature Orthopedics Pty Limited
Class II · Terminated
Class II FDA medical device recall by Signature Orthopedics Pty Limited, initiated 2018-12-10, terminated 2020-12-14. It names one FDA 510(k) clearance: K170613. Product: Genius Knee Cemented Tibial Component Product Usage: Knee replacement component. Reason: Product mix up.
- Recalling firm
- Signature Orthopedics Pty Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-10
- Terminated
- 2020-12-14
- Firm location
- Lane Cove West, N/A, Australia
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Reason for recall
Product mix up
Data sourced from openFDA. This site is unofficial and independent of the FDA.