Prodisc C SK cervical disc implant labeling mix-up recalled
Centinel Spine is recalling Prodisc C SK U.S. Implant Extra Large cervical disc replacement devices due to a labeling mix-up where 6mm implants were labeled as 5mm and 5mm implants were labeled as 6mm.
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: This is an FDA Class II medical device recall involving a significant risk of harm—implanting the wrong-sized cervical disc could cause serious surgical and post-operative complications. The source text does not report actual injuries or illnesses, making it a theoretical risk scenario consistent with a High (3) severity classification.
Plain-English summary
Centinel Spine, Inc. is recalling Prodisc C SK U.S. Implant Extra Large cervical disc replacement devices (Model Number PDSXL6, Lot Number 2026-0027) due to a labeling error. The 6mm implants were incorrectly labeled as 5mm, and the 5mm implants were incorrectly labeled as 6mm.
This labeling mix-up could result in the wrong size implant being used during cervical spine surgery if the discrepancy is not caught before implantation.
The recalled devices were distributed nationwide in the states of Arizona, California, Georgia, Louisiana, Missouri, New York, Tennessee, and Texas. A total of 30 units were affected.
Patients who have received this implant or healthcare providers who have this product in inventory should contact Centinel Spine, Inc. immediately for instructions on identifying affected units and obtaining replacements or corrected labeling information.
The recalled product
- Product
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
- Manufacturer
- Centinel Spine, Inc.
- Hazard
- labeling-error
- surgical-implant-mismatch
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: PDSXL6
- UDI-DI: 00843193113986
- Lot Number: 2026-0027
Distribution
Distributed nationwide across the United States.