Trilliant Surgical, LLC recalls 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, R
Recalled 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
Hazard / Issue
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.
Issued by
FDA
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