Class II U.S. Food and Drug Administration

Berkeley Advanced Biomaterials, LLC Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI recall: Due to incorrect product label (Incorrect product name identified on outer

Recall published 11 months ago

Due to incorrect product label (Incorrect product name identified on outer packaging).

The hazard: Mislabelling or misbranding

Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

What the notice says: Due to incorrect product label (Incorrect product name identified on outer packaging).

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-0540-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Berkeley Advanced Biomaterials, LLC
Product type
Medical devices
Units affected
62 units
Distribution
Nationwide
Made in
United States
Lot / code info
Catalog Number: M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Lot Number: EBL10B13C Serial Numbers: EBL10112 - EBL10115 EBL10051-EBL10053, EBL10055-EBL10058 EBL10064 - EBL10073 EBL10075 - EBL10109
UPC codes
00816125023653

Products covered by this recall

Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

Check your product

The notice names 3 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.

  • 00816125023653

Serial number

On the rating plate, often next to the date of manufacture.

  • EBL10112 - EBL10115 EBL10051-EBL10053
  • EB

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

Berkeley Advanced Biomaterials, LLC — Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

  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. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  3. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  4. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: Berkeley Advanced Biomaterials, LLC — 2800 7th St, Berkeley, CA, 94710-2703

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 Berkeley Advanced Biomaterials, LLC medical devices recalled?

Due to incorrect product label (Incorrect product name identified on outer packaging). Due to incorrect product label (Incorrect product name identified on outer packaging).

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00816125023653. 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?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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