Recall Z-1237-2021— RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class II · Ongoing
Class II FDA medical device recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), initiated 2021-01-15. FDA's recall record names no specific 510(k) clearance for this event. Product: CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - 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.
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-01-15
- Firm location
- Marquette, MI, United States
Product description
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.