RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Defect
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 results in the need for 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 3 Level, 45mm configuration (Material Number: 66-345). The recall covers units distributed nationwide in the United States with specific batch numbers listed in the agency record.
The recall is being conducted because the locking mechanism has been observed to disassociate either during or after the surgical procedure. This defect can result in the need for replacement or revision surgery. The device is intended for anterior cervical fixation for conditions such as degenerative disc disease, spondylolisthesis, trauma, and spinal stenosis.
Healthcare providers and patients should contact RTI Surgical for instructions on how to manage the affected devices. The source text does not report specific instances of patient injury or death, but notes that the defect results in the need for surgical intervention.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - 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
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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FDA (Devices) · 2021-03-17
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