Z-1406-2021Class II

Prodisc C - prosthesis, intervertebral disc -

Name: Z-1406-2021 Prodisc C - prosthesis, intervertebral disc -
Creator: Centinel Spine, Inc.
Published: 2021-03-05
License: https://open.fda.gov/license/

Centinel Spine, LLC / initiated 2021-03-05 / Terminated / root cause: manufacturing process

FDA source

Centinel Spine, Inc. began a recall of Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following... on 2021-03-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1406-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-05
Posted: 2021-04-09
Terminated: 2021-08-02
Recalling firm: Centinel Spine, LLC
Product: 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
Product code: MJO Prosthesis, Intervertebral Disc
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: In March 2021, Centinel issued an Urgent Medical Device Recall notice to customers and distributers via letter and email notifying them the "UP" etching on the superior plate is missing. The "UP" is used to signify that the implant should be inserted into the intradiscal space with "UP" towards the head or in the cephalic position. In those devices with "UP" missing, there is a risk that the device could be placed upside-down within the intradiscal space.
Quantity in commerce: 49 devices
Distribution: US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.
Product codes and lots: UDI (01)00843193112842(17)241231(10)2020-0600 Lot number: 2020-0600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1406-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1406-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-09

Product code MJO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)