CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - 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-1205-2021
- 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, 1 Level, 12mm Material Number: 66-112 - 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: 328891 328893 328894 338794 340980 341495 344086 347925 347926 352672 358452 363412 363413 364047 367781 369328 370314 372189 372190 379399 379400 386003
US Nationwide distribution.