Recall Z-0939-2014 ยท MQV Filler, Bone Void, Calcium Compound
RTI Surgical, Inc.
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.
| Date | Feb 7, 2014 (initiated Dec 6, 2013) |
| Status | Terminated |
| Reason | RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts. |
| Root cause | Other |
| Action | RTI Surgical issued a: URGENT: Medical Device Recall Notification dated December 6, 2013 to their customer. The customer was instructed to quarantine the product immediately and return to RTI Surgical, Inc. for final disposition. For questions or concerns, call 386-418-8888. |
| Quantity | 14 units |
| Distribution | Distributed to Florida. |
| 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 |