Reported Mar 17, 2021 · Ongoing

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for…

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · 375 River Park Cir · Marquette, MI · 49855-1781

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm
Material Number66-468 -
Product Usageintended for anterior cervical fixation (C2-C7)
for the following conditionsdegenerative 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)

Lot codes and dates: Batch Number342454 348029 351952 357127 364539 370412 380678

The agency filed one notice per product. You are reading one of them; the other 40 are below.

28 more are in the archive.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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7 in total.