RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - 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, pseudathros Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - 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, pseudathros
Brand
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Lot Codes / Batch Numbers
Batch Number: 328891, 328892
Products Sold
Batch Number: 328891, 328892
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product due to Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Recommended Action
Per FDA guidance
Pioneer Surgical Technology, Inc. (DBA RTI Surgical) initiated email notification on 15 January 2021 via the Distributor. End Users notified via Distributor by First Class Mail. Letter states reason for recall, health risk and action to take: Remove from all user sites and inventory locations the CervAlign Anterior Cervical Plates listed in the attached distribution list. Kindly return CervAlign Anterior Cervical Plates RTI Surgical along with the appropriate forms. RTI Surgical is working on corrective actions to prevent these events from reoccurring. We do not know at this time how long this will take to apply these corrective actions, but as soon as we do, we will notify you. If you have any questions or concerns, please contact me at your earliest convenience. RTI Surgical apologizes for any inconvenience this caused Surgalign. Thank you for your cooperation. Contact: Director of Quality Pioneer Surgical (d.b.a. RTI Surgical), 375 River Park Circle, Marquette, MI 49855 U.S.A. (www.rtix.com) P: 763-238-2034 E: jduncan@rtix.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026