FDAFDA · Food and drugs·Recall number Z-1222-2021
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - 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: 333019 333020 338839 341491 346885 351526 354405 359842 359843 363443 364532 369362 370404 377837 379929 385416
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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