The Recall Desk
HighFDA (Devices)·Z-1829-2016·Announced 2016-06-01

RTI Surgical Recalls Streamline OCT Spinal Fixation Instruments

RTI Surgical is recalling 17 Streamline OCT Crosslink Counter Torque Sleeves because a defect may obstruct the cannula, potentially causing driver slippage and patient injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of patient injury due to mechanical failure, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling 17 units of the Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. These are spinal fixation device instruments identified by Lot Number 170684 and Part Number 26-COUNTER-T-XLINK.

The recall is due to a potential 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.

The affected devices were distributed nationwide in California, Florida, Indiana, Michigan, Missouri, North Carolina, New York, and Texas. Healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
Affected units
17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically: