RTI Surgical, Inc.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1441-2017 | Class II | RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine a | January 23, 2017 |
| Z-0939-2014 | Class II | ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and ort | December 6, 2013 |
| Z-0627-2014 | Class II | C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are | October 7, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253145 | Pre-Sutured Tendon | October 22, 2025 |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | February 21, 2025 |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | June 23, 2023 |
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | October 23, 2017 |
| K163673 | Fortilink-C with TETRAfuse 3D Technology | May 23, 2017 |
| K142070 | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS | October 27, 2014 |
| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | March 31, 2014 |