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Tribio Implant 7.5mm x 40mm REF M80 SB008 recallZ-0540-2026 · Berkeley Advanced Biomaterials, LLC · initiated Sep 2, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Berkeley Advanced Biomaterials, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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].

Recall details

Recall number
Z-0540-2026
Status
Open, Classified
Initiated by the company
Sep 2, 2025
Posted by the FDA
Nov 18, 2025
Recalling firm
Berkeley Advanced Biomaterials, LLC
Quantity
62 units
Product code
MQV
FDA submissions
K170917
Distribution
U.S. Nationwide distribution in the state of TN.

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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