Tribio Implant (Berkeley Advanced Biomaterials) – Incorrect Label (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Berkeley Advanced Biomaterials, LLC
Lot Codes / Batch Numbers
EBL10055-EBL10058 EBL10064 - EBL10073 EBL10075 - EBL10109
Products Sold
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
Berkeley Advanced Biomaterials, LLC is recalling Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tr due to Due to incorrect product label (Incorrect product name identified on outer packaging).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to incorrect product label (Incorrect product name identified on outer packaging).
Recommended Action
Per FDA guidance
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: qa@ostetic.com 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 sales@ostetic.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026