Centinel Spine Recalls Prodisc C SK Cervical Disc Replacement Devices Due to Mislabeled Sizing
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 recalls alert 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar alerts have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized fda recalls advisory is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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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.
Source: FDA Official Notice