Prodisc C — Class II medical device recall Z-1406-2021

Terminated recall by Centinel Spine, Inc., reported 2021-04-21, distributed nationwide. Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the s

Recall number	`Z-1406-2021`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Centinel Spine, Inc., West Chester, PA, United States
Recall initiated	2021-03-05
Classified	2021-04-09
Reported by FDA	2021-04-21
Terminated	2021-08-02
Distributed	Nationwide (US)
Quantity	49 devices
UPC / GTIN / UDI-DI	`00843193112842`
Lot numbers	`2020-0600`
Model numbers	`09.820.055S`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1406-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.