Recall Z-1239-2021 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - 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
| Date | Jan 15, 2021 |
| Status | Open, Classified |
| Reason | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision |
| Root cause | Under Investigation by firm |
| Action | 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 th |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.