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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98721

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 20, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Centinel Spine, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-2050-2026
Recall number
Z-2050-2026
Initiated
March 20, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Centinel Spine, Inc.
Quantity
30 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling mix up

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026

Distribution pattern

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

device · product 2 of 2

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

Z-2051-2026
Recall number
Z-2051-2026
Initiated
March 20, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Centinel Spine, Inc.
Quantity
30 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling mix up

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027

Distribution pattern

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