Signature Orthopedics Pty Limited
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1694-2021 | Class II | Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to | April 20, 2021 |
| Z-0833-2019 | Class II | Genius Knee Cemented Tibial Component Product Usage: Knee replacement component | December 10, 2018 |
| Z-0834-2019 | Class II | Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component | December 10, 2018 |
| Z-0920-2018 | Class II | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are | February 2, 2018 |