RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate during or after surgery, requiring revision.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device that results in revision surgery, which aligns with the rubric criteria for 'structural vehicle defect' or 'significant injury/property-damage reports' (interpreted here as significant medical intervention/revision).
Plain-English summary
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling the CervAlign Anterior Cervical Plate System, specifically the 4Level, 76mm model (Material Number: 66-476). The recall covers units with batch numbers 342456, 348031, 351954, 357128, 364540, 370414, 381213, 381525, and 383204. These devices were distributed nationwide in the United States.
The recall was initiated because the locking mechanism of the device has been observed to disassociate either intraoperatively (during surgery) or postoperatively (after surgery). This failure can result in the need for replacement or revision surgery. The device is intended for anterior cervical fixation (C2-C7) for conditions including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumors, pseudarthrosis, and failed previous fusion.
Healthcare providers and patients who have received this specific device should contact RTI Surgical for further instructions regarding the recall and potential revision procedures.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - 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 t
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 41 products in this recall →Related recalls
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