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Limited official informationFDA Medical Device Enforcement ReportsRecall date: May 13, 2026

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

Full official product description

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement. | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 3, 2026, 9:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.; Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

Identifiers to compare

  • UDI 00843193113979
  • UDI 00843193113986
  • Model PDSXL5
  • Model PDSXL6
  • Lot 2026-0026
  • Lot 2026-0027
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-002630 unitsZ-2050-2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-002730 unitsZ-2051-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.