CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - 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).
- Recall Initiated
- January 15, 2021
- Recall Number
- Z-1227-2021
- Firm Location
- Marquette, MI
Reason for Recall
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Distribution
US Nationwide distribution.
Lot / Code Info
Batch Number: 333154 338847 341490 347128 351533 359850 364536 367817 370409 378062 380154
Root Cause
Under Investigation by firm
Action Taken
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