FDA-Device2020-05-13Class II
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
Trilliant Surgical, LLC
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.
Sold states
US Nationwide distribution in the state of CA. OUS: None
Affected count
5 drill bits
Manufactured in
727 N Shepherd Dr Ste 100, N/A, Houston, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2020Don't want to check this manually?
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