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 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 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
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the CervAlign Anterior Cervical Plate System, specifically the 4Level, 64mm model (Material Number 66-464). The recall was initiated by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.).
The recall is due to reports that 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 affected units are identified by the following batch numbers: 342453, 348028, 351951, 357126, 364538, 370411, and 380157.
The product was distributed nationwide in the United States. The CervAlign system 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 should contact the manufacturer for instructions on how to handle the recalled devices.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - 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: 342453 348028 351951 357126 364538 370411 380157
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
- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
- SevereFDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
FDA (Devices) · 2021-03-17
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