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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Related recalls
Same manufacturer · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
See all →- SevereCervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
FDA (Devices) · 2021-03-17
- SevereCervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
FDA (Devices) · 2021-03-17
- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
- SevereFDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- SevereRTI Surgical Streamline OCT Final Driver Recalled for Fracture Risk
FDA (Devices) · 2016-04-20
- SevereRTI Surgical Recalls Streamline OCT Spinal Rods Due to Cracks
FDA (Devices) · 2016-10-26
- ModeratePioneer Surgical Technology Recalls Streamline CT Set Screws
FDA (Devices) · 2014-09-10
- ModerateRTI Surgical Recalls Streamline OCT Navigated Instruments Due to Missing Drill Guide
FDA (Devices) · 2020-11-11
- ModerateRTI Surgical Recalls Streamline TL Navigation System Taps Due to Binding
FDA (Devices) · 2020-11-04
- HighRTI Surgical Recalls Streamline MIS Navigation System Taps Due to Binding
FDA (Devices) · 2020-11-04