The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1228-2021·Announced 2021-03-17

CervAlign Anterior Cervical Plate System Recall for Locking Mechanism Failure

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device that results in revision surgery, meeting the criteria for a Severe rating (structural defect/significant injury).

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling the CervAlign Anterior Cervical Plate System, specifically the 4Level, 60mm model (Material Number 66-460). The recall covers specific batch numbers: 342452, 348027, 351950, 357125, 364537, 380155, 380156, and 385417. The product was distributed nationwide in the United States.

The recall was initiated because the locking mechanism has been observed to disassociate either during or after the surgical procedure. 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 who have received this specific device should contact their surgeon or the manufacturer for instructions on next steps. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The recalled product

Product
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - 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: 342452 348027 351950 357125 364537 380155 380156 385417

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 →

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