Z-1211-2021 Class II Ongoing
FDA device recall Z-1211-2021 was initiated by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) on January 15, 2021 and is designated Class II. Reason for recall: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- March 17, 2021
- Initiation Date
- January 15, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - 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
Distribution Pattern
US Nationwide distribution.
Code Information
Batch Number: 330510 330511 338826 344094 350507 355018 361793 361794 364054 372180 372181 377184 378427