The Recall Desk
SevereFDA (Devices)·Z-1233-2021·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 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.

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling the CervAlign Anterior Cervical Plate System, specifically the 4Level, 80mm model (Material Number: 66-480). The recall covers units with batch numbers 342457, 348032, 351955, 357129, 364769, and 381292. These devices were distributed nationwide in the United States.

The recall is being conducted because the locking mechanism has been observed to disassociate either during or after the surgical procedure. This failure has resulted in the need for replacement or revision surgery for affected patients. The device is intended for anterior cervical fixation (C2-C7) for conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudarthrosis, and failed previous fusion.

Healthcare providers and patients who have received this specific device should contact RTI Surgical, Inc. for further instructions regarding the recall and potential revision procedures.

The recalled product

Product
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - 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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Batch Number: 342457 348032 351955 357129 364769 381292

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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