CervAlign Anterior Cervical Plate System-Cervalign recall
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation…
Why was CervAlign Anterior Cervical Plate System-Cervalign recalled?
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch Number: 333152 333152 338845 341493 347126 351531 355537 359848 364534 364971 369364 370407 378060 380152
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation…
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Distribution
- US Nationwide distribution.
- Recall date
- March 17, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)