Centinel Spine Recalls Prodisc C SK Implant Due to Labeling Mix-Up

Source: FDA · United States

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Centinel Spine, Inc. is recalling 30 units of Prodisc C SK U.S. Implant Extra Large 6mm devices distributed nationwide due to a product labeling mix-up.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 26, 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. initiated a voluntary recall of the Prodisc C SK U.S. Implant Extra Large 6mm due to a product labeling mix-up. The 6mm product was labeled as 5mm and the 5mm product was labeled as 6mm.

Which Products Are Affected

The recall affects 30 units of Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM (Model Number: PDSXL6). The affected lot is 2026-0027 with UDI-DI 00843193113986. Distribution was limited to the states of AZ, CA, GA, LA, MO, NY, TN, and TX.

What You Should Do

Consumers and healthcare providers should check inventory for the affected devices and contact Centinel Spine, Inc. for return or replacement instructions.

Why This Matters

The labeling error could result in incorrect implant sizing during cervical disc replacement procedures.

Source

FDA Recall Z-2051-2026 - Centinel Spine, Inc., West Chester, PA

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Centinel Spine, Inc. is recalling 30 units of Prodisc C SK U.S. Implant Extra Large 6mm devices distributed nationwide due to a product labeling mix-up.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.