Z-1236-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 17, 2021
- Initiation Date
- January 15, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - 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).
Reason for Recall
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Distribution Pattern
US Nationwide distribution.
Code Information
Batch Number: 345227 352382 357123 364541 372302 382119