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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87530

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 05, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
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

1 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 1

Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S

Z-1406-2021
Recall number
Z-1406-2021
Initiated
March 05, 2021
Classification
Class II
Status
Terminated
Recalling firm
Centinel Spine, Inc.
Quantity
49 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.

Code information

UDI (01)00843193112842(17)241231(10)2020-0600 Lot number: 2020-0600

Distribution pattern

US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.