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

FDA device recall Z-0540-2026 · posted 2025-11-18 · Open, Classified

Recall details

Recalling firm

Berkeley Advanced Biomaterials, LLC

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

MQV

Quantity affected

62 units

Distribution

U.S. Nationwide distribution in the state of TN.

Date initiated

2025-09-02

Date posted

2025-11-18

Location

Berkeley, CA

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