Trilliant Surgical recalls 70 units of 3.5mm Aresenal Screw Drill Bits with labeling error that may cause misidentification and traceability issues. Affected items have specific lot numbers.
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.
Trilliant Surgical is recalling 70 units of 3.5mm Aresenal Screw Drill Bits due to a labeling error that could lead to misidentification and traceability problems. This affects medical devices used for implant insertion under prescription.
The drill bits from lot # TSL008495A are incorrectly labeled with the lot number of TSL008495. This labeling error could cause parts to be misidentified, potentially affecting device traceability in medical procedures.
Medical professionals who use the 3.5mm Aresenal Screw Drill Bits for implant procedures under prescription. Patients receiving these procedures are not directly affected by the labeling error.
Check for the lot number TSL008495A on the drill bits. The product is sold under prescription and has a specific UDI code (01)00812926029696.
Verify the lot number on the drill bit; affected units have lot # TSL008495A.
The drill bits from lot # TSL008495A are incorrectly labeled with the lot number of TSL008495, which could lead to misidentification and traceability issues.
Check for the lot number TSL008495A on the drill bit. The product is sold under prescription and has a specific UDI code (01)00812926029696.
No, the recall does not require stopping use; it only addresses labeling for traceability purposes.
We’ve drafted a message you can send Trilliant Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1892-2020 — Trilliant Surgical Trilliant Surgical Hello, I own a Trilliant Surgical that is covered by recall Z-1892-2020 from Trilliant Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
