Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is
Summary
The FDA issued a Class II for Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL by Berkeley Advanced Biomaterials, LLC. Reason: Due to incorrect product label (Incorrect product name identified on outer packaging)..
Details
Source
Device Recall
External ID
Z-0540-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
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.
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
Quantity Affected: 62 units
Reason for Recall
Due to incorrect product label (Incorrect product name identified on outer packaging).
Distribution
U.S. Nationwide distribution in the state of TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-02
Company
Berkeley, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 222 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Berkeley Advanced Biomaterials, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Berkeley Advanced Biomaterials, LLC have FDA actions?
This is the only FDA action we have on record for Berkeley Advanced Biomaterials, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0540-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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