RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for…

Recall date

January 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1227-2021

FDA classification

Class II

Brand / firm

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Sold / distributed

US Nationwide distribution.

Why it was recalled

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).