Home / Recalls / Medical Devices
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
Recalled June 1, 2016 · FDA recall Z-1829-2016 · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Hazard
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. · FDA Class II
Units
17 devices
Sold at
US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.
Description
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.
Product
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
Manufacturer(s)
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →