3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit fac...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1892-2020.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1892-2020.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Trilliant Surgical, Llc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1892-2020.
Trilliant Surgical, LLC
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Trilliant Surgical, Llc Recall FAQ
Trilliant Surgical, Llc is the subject of a medical implants safety report: 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit fac.... The notice was published on October 10, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 5 units are potentially affected.