Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CervAlign Anterior Cervical Plate System-Cervalign Recalled by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Due to Locking mechanism has been observed to disassociate either...
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
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
Why Was This Recalled?
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
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