RTI Surgical Recalls
3 recalls on record · January 15, 2014 to March 22, 2017 · Medical Devices
Recalls by year
14
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 22, 2017Medical DevicesFDA
RTI Surgical, Inc. recalls RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applic
Hazard: Incorrect instructions for use (IFU) included.
February 19, 2014Medical DevicesFDA
RTI Surgical, Inc. recalls ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications
Hazard: 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.
January 15, 2014Medical DevicesFDA
RTI Surgical, Inc. recalls C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical interverte
Hazard: As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a s