Prodisc C SK Cervical Implant Size Labeling Mix-Up Recall
Centinel Spine is recalling Prodisc C SK U.S. cervical disc implants due to a labeling mix-up: 6mm products were labeled as 5mm and 5mm products were labeled as 6mm, creating risk of implanting the wrong size.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for patient harm if wrong-sized implant is used during surgery. No illnesses or injuries have been reported, but the hazard is direct and substantial—implanting an incorrectly sized cervical disc could compromise surgical outcome and patient safety.
Plain-English summary
Centinel Spine, Inc. is recalling Prodisc C SK U.S. Implant Extra Large cervical disc replacements due to a labeling error. The 6mm product was incorrectly labeled as 5mm, and the 5mm product was incorrectly labeled as 6mm.
This labeling mix-up could result in surgeons implanting the wrong-sized disc during cervical spine replacement procedures, potentially compromising the surgical outcome and patient safety.
The affected product is Model PDSXL5 (UDI-DI: 00843193113979, Lot Number: 2026-0026). A total of 30 units were distributed nationwide across Arizona, California, Georgia, Louisiana, Missouri, New York, Tennessee, and Texas.
Patients and healthcare providers who have received or implanted these devices should contact Centinel Spine, Inc. immediately to verify the actual size of the product and determine whether corrective action is needed.
The recalled product
- Product
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Manufacturer
- Centinel Spine, Inc.
- Hazard
- labeling-error
- wrong-product-size
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 (3)
- Model Number: PDSXL5
- UDI-DI: 00843193113979
- Lot Number: 2026-0026
Distribution
Distributed nationwide across the United States.