Recall Z-1829-2016 ยท KWP Appliance, Fixation, Spinal Interlaminal
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
| Date | May 26, 2016 (initiated Apr 22, 2016) |
| Status | Terminated |
| Reason | Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury. |
| Root cause | Process design |
| Action | RTI sent an Urgent Voluntary Product Notification dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. RTI Surgical is conducting a voluntary recall of the Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve due to the potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip resulting in possible patient injury. For further questions, please call (9 |
| Quantity | 17 devices |
| Distribution | US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), Apr 28, 2015 |