PlainRecalls
FDA Devices Moderate Class II Ongoing

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - 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, pseudathros

Reported: March 17, 2021 Initiated: January 15, 2021 #Z-1204-2021

Product Description

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - 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

Details

Units Affected
65 units
Distribution
US Nationwide distribution.
Location
Marquette, MI

Frequently Asked Questions

What product was recalled? ▼
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - 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).. Recalled by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.). Units affected: 65 units.
Why was this product recalled? ▼
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 17, 2021. Severity: Moderate. Recall number: Z-1204-2021.

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