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 the source text explicitly states that the defect results in replacement or revision surgery, which constitutes a significant injury or medical complication.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the CervAlign Anterior Cervical Plate System, 1 Level, 14mm (Material Number: 66-114). The recall is being conducted by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.).
The recall was initiated because the locking mechanism of the device has been observed to disassociate either during surgery (intraoperatively) or after surgery (postoperatively). This failure results in the need for replacement or revision surgery for the patient.
The affected products were distributed nationwide in the United States. The specific batch numbers involved in this recall are 328895, 328896, and 328897. Healthcare providers and patients should contact the manufacturer for further instructions regarding the recall and potential replacement.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - 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: 328895 328896 328897
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
- SevereCervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
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- SevereRTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
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- 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
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