CervAlign Anterior Cervical Plate System Recalled for 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 is classified as FDA Class II and involves a structural defect in a medical device that results in the need for 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, 5 Level, 95mm (Material Number: 66-595). The recall affects units with batch numbers 345226, 352381, 357122, 369366, 372235, and 381293. These devices were distributed nationwide in the United States.
The recall is being conducted because the locking mechanism 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 for conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudarthrosis, and failed previous fusion.
Healthcare providers should contact RTI Surgical for instructions on how to handle the recalled devices and manage patients who have received them.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - 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
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: 345226 352381 357122 369366 372235 381293
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 →- SevereCervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
FDA (Devices) · 2021-03-17
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