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Recall Observatory FDA recall evidence

Device product

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - 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).

Z-1207-2021

January 15, 2021

Class II

Product summary

Firm
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Event
Event 87251
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1207-2021

Official wording

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

Code information: Batch Number: 328898 328899

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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