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Trilliant Surgical, LLC recalls 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage
Recalled May 13, 2020 · FDA recall Z-1892-2020 · Trilliant Surgical
Hazard
Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability. · FDA Class II
Units
5 drill bits
Sold at
US Nationwide distribution in the state of CA. OUS: None
Description
Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability.
Product
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion
Manufacturer(s)
Trilliant Surgical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →