Trilliant Surgical product recalled over sterility concerns

Recall date

October 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Trilliant Surgical, LLC recalls 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usag…

Recall number

Z-1892-2020

FDA classification

Class II

Brand / firm

Trilliant Surgical, LLC

Sold / distributed

US Nationwide distribution in the state of CA. OUS: None

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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