The Recall Desk
SevereFDA (Devices)·Z-1222-2021·Announced 2021-03-17

RTI Surgical 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 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 involves a structural defect in a medical device that has resulted in revision surgery, meeting the criteria for a Severe (Score 4) classification due to significant injury/property-damage reports or structural defects.

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling the CervAlign Anterior Cervical Plate System, 3 Level, 48mm (Material Number: 66-348). The recall involves specific batch numbers distributed nationwide in the United States.

The recall is being issued because the locking mechanism has been observed to disassociate either during or after surgery. This defect has resulted in the need for replacement or revision surgery for affected patients.

Healthcare providers and patients should contact RTI Surgical for further instructions regarding the affected devices. The source text does not specify the total number of units recalled or the number of patients affected.

The recalled product

Product
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - 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 / Spinal
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 →

Related recalls

Same manufacturer · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

See all →

Same hazard · structural failure

See all →