Centinel Spine Prodisc C SK Implant Recall for Labeling Mix-Up
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Centinel Spine, Inc. has initiated a Class II recall of 30 units of Prodisc C SK U.S. Implant Extra Large 5mm due to incorrect product labeling.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 25, 2026 and geographically references United States. 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 read it 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 notices 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 recall 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. is recalling certain Prodisc C SK implants because of a product labeling mix-up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and the prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Which Products Are Affected
The recall involves the Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM, Model: PDSXL5. A total of 30 units are affected. The recall covers US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX. Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026. Recall Number: Z-2050-2026.
What You Should Do
The recalling firm initiated the recall through two or more of the following methods: Email, Fax, Letter, Press Release, Telephone, Visit. Specific consumer instructions are not detailed in the recall notice.
Why This Matters
The labeling error on these cervical disc replacement implants may result in the wrong size device being used during procedures.
Source
FDA Enforcement Report, Recall Number Z-2050-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
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