FDA recall Z-1237-2021

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · Class II · device

Product

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - 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).

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2021-01-15
Report date
2021-03-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marquette, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2021