RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System 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 has resulted in revision surgery, meeting the criteria for a Severe rating.
Plain-English summary
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling specific batches of the CervAlign Anterior Cervical Plate System, 3Level, 51mm (Material Number: 66-351). The recall is due to reports that 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.
The affected product is intended for anterior cervical fixation (C2-C7) for conditions including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumors, pseudarthrosis, and failed previous fusion. The recall covers units with specific batch numbers listed in the agency's records, including 333021, 333022, 338840, and others. The product was distributed nationwide in the United States.
Healthcare providers and patients should check their inventory or medical records for the affected batch numbers. If the product is in use, providers should contact RTI Surgical for instructions on replacement or revision. Patients who have had this specific device implanted should consult their surgeon to determine if their device is affected and if further action is required.
The recalled product
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - 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 t
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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