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Lower risk Medical device recall · FDA · Published March 5, 2021

Centinel Spine Prodisc C Disc Prosthesis Recall: Missing UP Etching

Centinel Spine recalls Prodisc C intervertebral disc implants missing the UP etching on the superior plate, which can lead to improper placement during surgery. Affected units sold from 2020-06-01.

🇺🇸 FDA recall #Z-1406-2021Medical deviceCentinel Spine ›
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Recalling firmCentinel Spine, Inc.900 Airport Rd Ste 3b · West Chester, PA 19380-3416
✎ GovInfoNow plain-language explainer

Centinel Spine is recalling Prodisc C spinal implants that may lack the "UP" etching on the superior plate. This could cause improper surgical placement if the surgeon doesn't follow the correct orientation. The recall affects patients who received the device for cervical disc reconstruction. Read more at govinfonow.com/recall/63154-centinel-spine-prodisc-c-disc-prosthesis-recall-missing-up-etching.

Source Summary by GovInfoNow · govinfonow.com/recall/63154-centinel-spine-prodisc-c-disc-prosthesis-recall-missing-up-etching · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1406-2021

Cite this page

“Centinel Spine Prodisc C Disc Prosthesis Recall: Missing UP Etching.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63154-centinel-spine-prodisc-c-disc-prosthesis-recall-missing-up-etching. Based on FDA recall #Z-1406-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1406-2021%22&limit=1).

The FDA announced on March 5, 2021, that Centinel Spine, Inc. is recalling the Prodisc C intervertebral disc prosthesis because some units are missing the "UP" etching on the superior plate. The agency stated this defect could lead to improper implantation by surgeons.

How to tell if you have it

  • Brand: Centinel Spine
  • Product: Prodisc C - prosthesis, intervertebral disc
  • Part number: 09.820.055S
  • UDI: (01)00843193112842(17)241231(10)2020-0600
  • Lot number: 2020-0600
  • UPC: 00843193112842

The hazard

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, this etching indicates the direction in which the surgeon should place the device into the intradiscal space.

Context

GovInfoNow's records show Centinel Spine, Inc. has had three other recalls since July 18, 2024, including a labeling mix-up on March 20, 2026, and mislabeling of disc sizes on Dec. 31, 2025. Other recent recalls of similar products include the Zimmer Persona Revision Femoral Distal Augment Recall (May 11, 2026), the SeaSpine Mariner Deformity Product Recall (Aug. 19, 2026), and the Novapproach OneLIF Interbody Cage Recall (April 23, 2026).

How to tell if you have this one

Check for the "UP" etching on the superior plate of the Prodisc C device. Affected units have part number 09.820.055S and lot number 2020-0600, sold starting June 2020.

  • Brand
    Centinel Spine
  • Product
    Prodisc C - prosthesis, intervertebral disc
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Marking

    Look for the "UP" etching on the superior plate of the Prodisc C device. If missing, the unit is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 13 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, District of Columbia, Florida, Georgia, Kentucky, Maryland, Michigan, New York, North Carolina, Ohio, Pennsylvania, Tennessee.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Mar 5, 202112. FDA classified it Class II: Apr 9, 202123. Published in FDA’s Enforcement Report: Apr 21, 202134. FDA terminated the recall: Aug 2, 202142021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a fix for this issue?

The recall does not include a remedy; affected units must be checked for the marking and verified with the manufacturer.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1406-2021 (March 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1406-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA