Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
3.5mm Aresenal Screw Drill Bit Recalled by Trilliant Surgical, LLC Due to Labeling Error; specifically, drill bits from lots #...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Trilliant Surgical, LLC directly.
Affected 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
Quantity: 5 drill bits
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Trilliant Surgical, LLC
Trilliant Surgical, LLC has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report