Reported Mar 17, 2021 · Ongoing
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - 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
Is this the product you have?
- CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm
- Material Number66-360 -
- 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 Number
333153338846341494347127351532359849364535364767369365370408378061380153
- Batch Number
This recall covers 41 products
The agency filed one notice per product. You are reading one of them; the other 40 are below.
28 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
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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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