RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 3Level,
Recalled Product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - 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).
Hazard / Issue
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Issued by
FDA
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