The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1209-2021·Announced 2021-03-17

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

RTI Surgical is recalling specific 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 the need for revision surgery, which aligns with the rubric criteria for 'Severe' (structural defect/significant injury).

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling the CervAlign Anterior Cervical Plate System, 1 Level, 20mm (Material Number: 66-120). The recall covers units distributed nationwide in the United States with specific batch numbers: 329483, 338820, 344091, 348578, 353381, 363435, 364051, 367788, 372225, 372226, and 379406.

The recall was initiated because the locking mechanism of the device has been observed to disassociate either during or after surgery. 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 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, 1 Level, 20mm Material Number: 66-120 - 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

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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