Berkeley Advanced Biomaterials recalls specific Tribio Implant models with incorrect product labels on packaging. Affected units may have labeling errors that could lead to improper use in medical procedures.
Due to incorrect product label (Incorrect product name identified on outer packaging).
Berkeley Advanced Biomaterials is recalling certain Tribio Implant 7.5mm x 40mm models due to incorrect product labels on the packaging. This labeling error could lead to improper use during medical procedures if the implant is not correctly identified.
The product label on the packaging is incorrect, which could cause confusion about the implant's specifications. This might lead to improper use during medical procedures if the implant is not correctly identified.
Medical professionals who use these implants during surgeries are most at risk. Patients receiving the implants may be affected if the incorrect labeling leads to improper surgical procedures.
Check for the UDI code (01) 00816125023653(10) EBL10B13C(17) 270630 on the packaging. The affected units have specific serial numbers ranging from EBL10051 to EBL10109.
Verify the product label on the packaging for the UDI code (01) 00816125023653(10) EBL10B13C(17) 270630.
The recall record states the product is incorrectly labeled, but does not specify the correct product name.
Check for the UDI code (01) 00816125023653(10) EBL10B13C(17) 270630 on the packaging and serial numbers from EBL10051 to EBL10109.
The recall record does not specify a remedy, so no action is required beyond checking the label.
We’ve drafted a message you can send Berkeley Advanced Biomaterials to request your refund or repair — edit it as you like.
Subject: Recall Z-0540-2026 — Berkeley Advanced Biomaterials Berkeley Advanced Biomaterials Hello, I own a Berkeley Advanced Biomaterials that is covered by recall Z-0540-2026 from Berkeley Advanced Biomaterials. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
