FDAFDA · Food and drugs·Recall number Z-1217-2021
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - 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).
Published March 17, 2021 · Recall initiated: January 15, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Distributor
- US Nationwide distribution.
- Lot
- Batch Number: 332504 338834 344103 350521 353385 361808 364753 367807 370398 379081
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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