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Terminated

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

FDA Recall Z-1829-2016 · Posted 2016-05-26

Recalling FirmRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Recall StatusTerminated
Product CodeKWP
Date Initiated2016-04-22
Date Terminated2017-02-08
Product Quantity17 devices

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.

Firm 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 (906) 226-4489.

Root Cause

Process design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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