Class 2 Device Recall Tribio Implant

• Date Initiated by Firm: September 02, 2025
• Date Posted: November 18, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0540-2026
• Recall Event ID: 97601
• 510(K)Number: K170917
• Product Classification: Filler, bone void, calcium compound - Product Code MQV
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Berkeley Advanced Biomaterials, LLC; 2800 7th St; Berkeley CA 94710-2703
• For Additional Information Contact: Joel Strod; 510-883-0500 Ext. 23
• Manufacturer Reason for Recall: Due to incorrect product label (Incorrect product name identified on outer packaging).
• FDA Determined 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: 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.
• Quantity in Commerce: 62 units
• Distribution: U.S. Nationwide distribution in the state of TN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MQV