The Recall Desk
SevereFDA (Devices)·Z-1238-2021·Announced 2021-03-17

FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

RTI Surgical is recalling 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 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, 5 Level, 75mm (Material Number: 66-575). The device 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 is due to reports that the locking mechanism has been observed to disassociate either intraoperatively or postoperatively. This failure has resulted in the need for replacement or revision surgery. The affected batch numbers are 345222, 352337, 357118, 364543, 372238, 382115, and 386005.

The product was distributed nationwide in the United States. Patients who have had this device implanted should contact their healthcare provider to discuss the recall and determine if further evaluation or intervention is necessary.

The recalled product

Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - 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
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: 345222 352337 357118 364543 372238 382115 386005

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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