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Recall Observatory FDA recall evidence

Device product

Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.

Z-1829-2016

April 22, 2016

Class II

Product summary

Firm
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Event
Event 74031
Status
Terminated
Classification
Class II
Quantity
17 devices
Official record key
device-enforcement:Z-1829-2016

Official wording

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.

Code information: Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve; Lot Number: 170684; Part Number: 26-COUNTER-T-XLINK

Distribution pattern: US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.