The Recall Desk
SevereFDA (Devices)·Z-1234-2021·Announced 2021-03-17

RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure

RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate during or after 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 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, 84mm model (Material Number: 66-484). The recall covers units with batch numbers 342458, 348033, 351956, 357130, 364770, 370416, and 381526. These devices were distributed nationwide in the United States.

The recall was initiated because the locking mechanism has been observed to disassociate either intraoperatively or postoperatively. This failure can result in the need for replacement or revision surgery. 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.

Healthcare providers and patients who have used or are scheduled to use these specific batches of the CervAlign Anterior Cervical Plate System should contact RTI Surgical for further instructions regarding the recall and potential replacement or revision procedures.

The recalled product

Product
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - 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: 342458 348033 351956 357130 364770 370416 381526

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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