The Recall Desk
SevereFDA (Devices)·Z-1237-2021·Announced 2021-03-17

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

RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring surgical revision.

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. According to the rubric, FDA Class II recalls with reports of significant injury or property damage (in this case, the need for revision surgery due to device failure) are classified as Severe (Score 4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the CervAlign Anterior Cervical Plate System, 5 Level, 105mm (Material Number: 66-5105), manufactured by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.). The recall affects units with batch numbers 345228, 352383, 357124, 364542, 370440, and 382120, which were distributed nationwide in the United States.

The recall was initiated because the locking mechanism of the device has been observed to disassociate either during surgery (intraoperatively) or after surgery (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 such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumors, pseudarthrosis, and failed previous fusion.

Healthcare providers and patients should contact RTI Surgical, Inc. for further information regarding the recall and potential corrective actions. The source text does not specify the number of affected units or report specific injuries or illnesses.

The recalled product

Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - 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 o
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: 345228 352383 357124 364542 370440 382120

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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