Centinel Spine Recalls Prodisc C SK Cervical Disc Replacement Devices Due to Mislabeled Sizing
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Centinel Spine, Inc. is recalling 20 units of Prodisc C SK cervical disc replacements because 5mm devices were mislabeled as 6mm, affecting eight states.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee, Texas. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Centinel Spine, Inc. has initiated a voluntary recall of its Prodisc C SK total cervical disc replacement devices. The recall was issued after it was discovered that units were mislabeled; specifically, 5mm products were incorrectly packaged and labeled as 6mm products.
Which Products Are Affected
The recall involves 20 units of the following medical device:
- Brand Name: Prodisc
- Product Name: Prodisc C SK
- Model/Catalog Number: PDSL6
- Lot Number: 2025-0776
- UDI-DI: 00843193113924
The affected units were distributed across the following states: Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee, and Texas.
What You Should Do
Centinel Spine, Inc. notified affected customers via letter starting December 31, 2025. Healthcare facilities and providers should immediately check their inventory for Lot 2025-0776. Any affected units should be quarantined and returned to the manufacturer. For further information or to coordinate a return, contact Centinel Spine, Inc. at their West Chester, Pennsylvania headquarters.
Why This Matters
Accurate labeling is critical for surgical implants. The use of an incorrectly sized cervical disc replacement could lead to surgical complications, improper fit, or the need for revision surgery if the error is not caught prior to implantation.
Source
Information provided by the FDA under Recall Number Z-1426-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,434 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.