The Recall Desk
SevereFDA (Devices)·Z-1212-2021·Announced 2021-03-17

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 has resulted in revision surgery, meeting the criteria for a Severe rating 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 2Level, 26mm model (Material Number: 66-226). The recall is due to reports that the locking mechanism has been observed to disassociate either during or after the surgical procedure. This defect has resulted in the need for replacement or revision surgery for affected patients.

The affected product 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. The recall covers units distributed nationwide in the United States. Specific batch numbers affected include 330512, 330513, 338827, 340984, 344095, 350509, 350510, 352675, 361797, 364055, 364747, 367798, 370387, 372182, 377185, and 378428.

Healthcare providers and patients who have received this device should contact RTI Surgical or their healthcare provider for further instructions regarding potential revision surgery. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - 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 · mechanical failure

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