FDA Recalls CervAlign Anterior Cervical Plate System Due to 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 the need for revision surgery, 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, 1 Level, 12mm (Material Number: 66-112), manufactured by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.). The recall covers specific batch numbers distributed nationwide in the United States.
The recall is being conducted because the locking mechanism of the device has been observed to disassociate either during or after the surgical procedure. This failure can result in the need for replacement or revision surgery for the patient.
Healthcare providers and patients who have received this specific device should contact RTI Surgical, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - 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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- SevereFDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
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- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
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