CervAlign Anterior Cervical Plate System-Cervalign recall
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - 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: 333150 338842 341492 347125 351529 351530 358480 359845 364533 367814 369363 370406 377839 380043 380044 381527 381528 382443 382444 382445
- Product
- CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - 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)