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Prodisc C recallZ-1406-2021 · Centinel Spine, Inc. · initiated Mar 5, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Centinel Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-1406-2021
Status
Terminated
Initiated by the company
Mar 5, 2021
Recalling firm
Centinel Spine, Inc.
Quantity
49 devices
Product code
MJO
FDA submissions
P070001
Distribution
US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

45 devices cleared under P070001 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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