Prodisc C SK U.s. Implant Extra Large 5mm recall: Labeling Error
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Why was Prodisc C SK U.s. Implant Extra Large 5mm recalled?
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
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?
Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026
- Product
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Recalling firm
- Centinel Spine, Inc.
- Quantity
- 30 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
- Recall date
- May 13, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)