FDAJanuary 15, 2021device

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - 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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

rti surgical inc dba pioneer surgical technology incrtirti surgical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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