Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
- Recall Initiated
- April 22, 2016
- Posted
- May 26, 2016
- Terminated
- February 8, 2017
- Recall Number
- Z-1829-2016
- Quantity
- 17 devices
- Firm Location
- Marquette, MI
Reason for Recall
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.
Distribution
US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.
Lot / Code Info
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve; Lot Number: 170684; Part Number: 26-COUNTER-T-XLINK
Root Cause
Process design
Action Taken
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 (906) 226-4489.