Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod Recalled by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Due to RTI Surgical Inc. (RTI) is conducting a voluntary...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) directly.
Affected Products
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
Quantity: 66
Why Was This Recalled?
RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline¿ OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) has 50 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report