# FDA recall Z-1406-2021

> **Centinel Spine, Inc.** · Class II · device recall initiated 2021-03-05.

## 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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1406-2021
- **Recalling firm:** Centinel Spine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-05
- **Report date:** 2021-04-21
- **Termination date:** 2021-08-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1406-2021

## Citation

> AI Analytics. FDA recall Z-1406-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1406-2021. Source: US FDA. Licensed CC0.

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