CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems 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 results in revision surgery, 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, specifically the 2Level, 32mm model (Material Number 66-232). The recall covers units distributed nationwide in the United States with specific batch numbers listed in the agency record.
The recall is being issued because the locking mechanism of the device has been observed to disassociate either during the surgical procedure or after the patient has recovered. This mechanical failure can result in the need for replacement or revision surgery.
The product is intended for anterior cervical fixation (C2-C7) for conditions including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumors, and failed previous fusion. Because this is a medical device used in surgical procedures, patients who have had this specific device implanted should contact their healthcare provider to discuss the recall and determine if any follow-up action is necessary.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - 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.)
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
FDA (Devices) · 2021-03-17
- 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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