Centinel Spine, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1406-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 5, 2021

Date Posted: April 21, 2021

Recall Number: Z-1406-2021

Event ID: 87530

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.

Status: Terminated

Product Quantity: 49 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated