Z-0540-2026Class II

Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio"...

Name: Z-0540-2026 Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio"...
Creator: Berkeley Advanced Biomaterials, LLC
Published: 2025-09-02
License: https://open.fda.gov/license/

Berkeley Advanced Biomaterials / initiated 2025-09-02 / Open, Classified / root cause: manufacturing process

FDA source

Berkeley Advanced Biomaterials, LLC began a recall of 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... on 2025-09-02. FDA classified it as Class II and gives the reason as "Due to incorrect product label (Incorrect product name identified on outer packaging)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0540-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-02
Posted: 2025-11-18
Recalling firm: Berkeley Advanced Biomaterials
Product: 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.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Due to incorrect product label (Incorrect product name identified on outer packaging).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Between 09/02/2025 to 10/21/2025, the firm emailed an "URGENT-MEDICAL DEVICE RECALL" Letter to customers informing then that affected Tribio Implants have incorrect outer box labeling. The product itself is not defective, but the packaging label does not accurately reflect the product name. The issue of incorrect labeling on the packaging relates solely to the product description, which mistakenly lists the item as a 'Resorbable Bead kit' instead of its correct designation, 'Tribio" Implant.' Customers are instructed to: 1. QUARANTINE all affected products immediately. 2. DO NOT USE any implants with the serial numbers listed above. 3. CHECK YOUR INVENTORY against the lot and associated serial number list provided. 4. Follow the instructions below to return a product. 5. Please complete and sign the attached Field Correction Response Form. 6. Please send the completed and signed form within five (5) business days to one of the following options: Mail: Berkeley Advanced Biomaterials. Attention: Quality Assurance Department 2800 Seventh Street Berkeley, CA 94710 Email: [email protected] 7. You will receive a Returned Goods Authorization (RGA) by email, which will include detailed instructions for returning the affected products to Berkeley Advanced Biomaterials, LLC. 8. Additionally, if you have further distributed this product, please identify your customers and notify them accordingly. 9. At one point in this product Field Correction, your notification to your customers may be enhanced by including a copy of this product Field Correction letter. 10. Please contact Berkeley Advanced Biomaterials immediately via the phone number or email address below to arrange the return of the indicated product. 11. If you have any questions regarding the use of the product, please contact our customer service department at +1(510) 883-0500, Ext. 15, or email [email protected].
Quantity in commerce: 62 units
Distribution: U.S. Nationwide distribution in the state of TN.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0540-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0540-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-18

Product code MQV

K170917Class IIBi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials / cleared 2017-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)