FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.
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 is classified as FDA Class II and involves a structural defect in a medical implant that has resulted in reported revision surgeries, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the CervAlign Anterior Cervical Plate System, specifically the 2Level, 42mm model (Material Number: 66-242). The recall is being conducted by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.).
The recall is due to reports that the locking mechanism has been observed to disassociate either during or after the surgical procedure. This failure can result in the need for replacement or revision surgery. The affected product is intended for anterior cervical fixation (C2-C7) for conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudarthrosis, and failed previous fusion.
The recall covers units distributed nationwide in the United States. The specific batch numbers affected are 332506, 338836, 342573, 344105, 350523, 361814, 364756, 366089, 369339, and 379083. Healthcare providers and patients should contact the manufacturer for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - 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
Same manufacturer · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
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