Djo Surgical
FDA Regulatory Profile
Djo Surgical appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1130-2014, Class II) was initiated on February 7, 2014. Its most recent 510(k) clearance was granted on October 27, 2009.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1130-2014 | Class II | FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip system | February 7, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K092873 | REVERSE SHOULDER PROSTHESIS | October 27, 2009 |