Recall Z-1441-2017 ยท MQV Filler, Bone Void, Calcium Compound
RTI Surgical, Inc.
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
| Date | Jan 23, 2017 |
| Status | Terminated |
| Reason | Incorrect instructions for use (IFU) included. |
| Root cause | Labeling Change Control |
| Action | The firm, RTI Surgical, Inc., issued and "IMPORTANT NOTIFICATION Field Action" letter dated January 20th, 2017 to its consignee via e-mail on 01/23/2017. Verification and confirmation of the e-mail was received on the same date. The letter described the product, problem and actions to be taken. The consignee were instructed to immediately quarantine any grafts in your possession; return any unused RTI and include return authorization along with instructions on how to return the product. If you have any questions, Sr. Manager, Regulatory Compliance at 386-418-8888 ext. 4396 or email: amcconne |
| Quantity | 24 units |
| Distribution | International Distribution: Colombia only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043421 | OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC Regeneration Technologies, Inc., Feb 16, 2005 |