Trilliant Surgical Recalls 3.5mm Aresenal Screw Drill Bits Due to Labeling Error
Trilliant Surgical, LLC is recalling 3.5mm Aresenal Screw Drill Bits due to a labeling error where the lot number is incorrectly marked, potentially impacting device traceability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that impacts traceability but does not present an immediate risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Trilliant Surgical, LLC is recalling 3.5mm Aresenal Screw Drill Bits (Ref: 330-35-001) due to a labeling error. The recall involves 5 drill bits from Lot # TSL008495A. These products are prescription-only, non-sterile, and are used to facilitate implant insertion.
The specific issue is that the drill bits from Lot # TSL008495A are marked with the lot number TSL008495. This discrepancy could lead to parts being misidentified and may impact the traceability of the devices.
The affected products were distributed nationwide in the United States, specifically within the state of California. No distribution outside the US is reported. Healthcare providers and patients should stop using these specific drill bits and contact the manufacturer for further instructions.
The recalled product
- 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
- Trilliant Surgical, LLC
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # TSL008495A
Distribution
Related recalls
Same manufacturer · Trilliant Surgical, LLC
See all →- ModerateTrilliant Surgical Twist Sublatar Implant System Instructions for Use Recall
FDA (Devices) · 2020-04-08
- ModerateTrilliant Surgical Small Joint Reaming System Instructions for Use Recall
FDA (Devices) · 2020-04-08
- ModerateTrilliant Surgical Recalls 8mm Hammer Toe Reaming Kits Due to Incorrect Contents
FDA (Devices) · 2020-04-08
- ModerateTrilliant Surgical Recalls Instructions for Use for Cannulated Screw Systems
FDA (Devices) · 2020-04-08
- ModerateTrilliant Surgical Recalls Instructions for Use for Tiger Screw Systems
FDA (Devices) · 2020-04-08
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- SevereTrilliant Gridlock Ankle Screw Driver Bit Recalled for Specification Defect
FDA (Devices) · 2020-01-22
- ModerateTrilliant Surgical Recalls 3.0/4.0 Cannulated Drill Bits Due to Sizing Issue
FDA (Devices) · 2015-09-02
- HighTrilliant Gridlock Screw Driver Bits Recalled for Out-of-Specification Dimensions
FDA (Devices) · 2015-09-16
- ModerateOrthofix Drill Bits Recalled Due to Geometric Design Defect
FDA (Devices) · 2019-11-20
- ModerateOrthoPediatrics Recalls 2.5mm Drill Bits Due to Packaging Labeling Error
FDA (Devices) · 2013-08-21
- ModerateBrasseler Twist Drills Recalled Due to Incorrect Laser Etching
FDA (Devices) · 2019-12-11