CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - 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-1221-2021
- 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, 3 Level, 45mm Material Number: 66-345 - 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: 333017 333018 338838 346883 346884 351525 354404 358458 359841 364531 369361 370402 377835 377836 379927
US Nationwide distribution.