Class II U.S. Food and Drug Administration

Centinel Spine, Inc. Brand Name: Prodisc Product Name: Prodisc C SK Model/ recall: Products were mislabeled as the 6mm product but included the 5 mm product

Recall published 8 months ago

Products were mislabeled as the 6mm product but included the 5 mm product.

The hazard: Mislabelling or misbranding

The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

What the notice says: Products were mislabeled as the 6mm product but included the 5 mm product.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1426-2026
Published
February 25, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Centinel Spine, Inc.
Product type
Medical devices
Units affected
20 units
Distribution
Nationwide
Made in
United States
Lot / code info
Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
UPC codes
00843193113924

Products covered by this recall

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00843193113924

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2025-0776

Model or item number

On the rating label, the box or the instruction sheet.

  • PDSL6 Software Version
  • PDSL6

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Centinel Spine, Inc. — The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  3. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  4. Keep a photo of the mismatched label, which makes the refund conversation much shorter.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Centinel Spine, Inc. — 900 Airport Rd Ste 3b, West Chester, PA, 19380-3416

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Centinel Spine, Inc. medical devices recalled?

Products were mislabeled as the 6mm product but included the 5 mm product. Products were mislabeled as the 6mm product but included the 5 mm product.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00843193113924; lot code 2025-0776; model number PDSL6 Software Version, PDSL6. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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