Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-1406-2021

March 05, 2021

Class II

Product summary

Firm
Centinel Spine, Inc.
Event
Event 87530
Status
Terminated
Classification
Class II
Quantity
49 devices
Official record key
device-enforcement:Z-1406-2021

Official wording

Reason: 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.

Derived failure modes

  • 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.