FDASeptember 2, 2025device

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 traum...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

berkeley advanced biomaterialsberkeleyberkeley advanced

UPCs

00816125023653

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

CPSCHonlyne LED Party Favors Recalled Due to Risk of Serious Injury Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries; Sold by Huizhou Rongheng Network Technology2026-06-25
FDABrand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profo...2026-04-30
FDABrand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: ...2026-03-23
FDABrand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-1502025-11-27
FDATESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-012025-10-03
FDATESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-012025-05-30
FDAHiResolution" Bionic Ear System - M Battery Charger Model Number CI-56072025-03-05
FDAMcKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.2024-10-01

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