CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - 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).
Enforcement
- Recall Number
- Z-1219-2021
- Event ID
- 87251
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- March 17, 2021
- Initiation Date
- January 15, 2021
- Classification Date
- March 11, 2021
- Address
- 375 River Park Cir, Marquette, MI, 49855-1781, United States
Description
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - 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).
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Batch Number: 332506 338836 342573 344105 350523 361814 364756 366089 369339 379083
US Nationwide distribution.