The Recall Desk
SevereFDA (Devices)·Z-1224-2021·Announced 2021-03-17

CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure

RTI Surgical is recalling specific 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 involves a structural defect in a medical device that has resulted in reported revision surgeries, meeting the criteria for a Severe (Score 4) classification due to significant injury/property-damage reports or structural defects.

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling the CervAlign Anterior Cervical Plate System, specifically the 3Level, 54mm model (Material Number: 66-354). The recall covers units with specific batch numbers distributed nationwide in the United States.

The recall is being conducted because the locking mechanism has been observed to disassociate either during or after surgery. This failure has resulted in the need for replacement or revision surgery for affected patients.

Healthcare providers and patients should check their inventory and surgical records for the affected material number and batch numbers. If the product is in use or has been implanted, providers should contact the manufacturer for instructions on managing the device and potential revision procedures.

The recalled product

Product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - 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
Manufacturer
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Category
Medical Device — Orthopedic Implant
Hazard

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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Same hazard · structural failure

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