CervAlign Anterior Cervical Plate System Recall for Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 device that has resulted in reported revision surgeries, meeting the criteria for a Severe rating.
Plain-English summary
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling the CervAlign Anterior Cervical Plate System, 4Level, 72mm (Material Number: 66-472). The recall covers specific batch numbers: 342455, 348030, 351953, 356880, 359851, 380679, 380680, and 385418. The product was distributed nationwide in the United States.
The recall was initiated because the locking mechanism has been observed to disassociate either during or after the surgical procedure. This failure results 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, tumor, pseudarthrosis, and failed previous fusion.
Patients who have had this specific device implanted should contact their surgeon or healthcare provider to discuss the recall and potential next steps. The recall is classified as Class II by the FDA.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - 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…
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Number: 342455 348030 351953 356880 359851 380679 380680 385418
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.)
See all →- SevereCervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
FDA (Devices) · 2021-03-17
- SevereCervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
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- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
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- SevereFDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
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