Centinel Spine Recalls Prodisc C SK Implant Due to Labeling Mix-Up
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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 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, Devices.
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 ↗
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 (892 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.