FDA Enforcement
Class II
Ongoing
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - 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).
Recall: Z-1204-2021
·
Reported March 17, 2021
Enforcement
- Recall Number
- Z-1204-2021
- 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, 10mm Material Number: 66-110 - 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
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Code Info
Batch Number: 328891, 328892
Distribution
US Nationwide distribution.
Quantity
65 units