Class II — Centinel Spine, Inc.
| Recalling firm | Centinel Spine, LLC |
|---|---|
| Registered facility | CENTINEL SPINE, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 49 devices |
| Distribution | US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI. |
| Initiated | 2021-03-05 |
| Classified | 2021-04-09 |
| Terminated | 2021-08-02 |
| Recall number | Z-1406-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Centinel Spine, Inc. (Z-1406-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87530/
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