Reported Jun 1, 2016 · Terminated
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · 375 River Park Cir · Marquette, MI · 49855-1781
Is this the product you have?
- Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
- Lot codes and dates
- Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve
- Lot Number170684
- Part Number26-COUNTER-T-XLINK
- Amount recalled
- 17 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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