Synthes USA
FDA Regulatory Profile
Synthes USA appears in FDA public data with 2 recalls, 11 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0617-2018, Class II) was initiated on August 10, 2017. Its most recent 510(k) clearance was granted on November 10, 2016.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0617-2018 | Class II | Norian Drillable Inject | August 10, 2017 |
| Z-0618-2018 | Class II | Norian Drillable Inject | August 10, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | November 10, 2016 |
| K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM | March 30, 2015 |
| K121601 | SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE | July 6, 2012 |
| K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | June 19, 2012 |
| K120854 | SYNTHES VA LCP ANKLE TRAUMA SYSTEM | June 18, 2012 |
| K120717 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) | May 8, 2012 |
| K120070 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM | March 21, 2012 |
| K120083 | SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) | February 8, 2012 |
| K110592 | 3.7MM/5.0MM DYNAMIC LOCKING SCREW | July 25, 2011 |
| K110125 | 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM | April 21, 2011 |
| K110354 | 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM | March 4, 2011 |