Recall Z-1829-2016— RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class II · Terminated
Class II FDA medical device recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), initiated 2016-04-22, terminated 2017-02-08. It names one FDA 510(k) clearance: K150254. Product: Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.. 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..
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-22
- Terminated
- 2017-02-08
- Firm location
- Marquette, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.