Reported May 13, 2020 · Terminated
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product…
Trilliant Surgical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Trilliant Surgical, LLC · 727 N Shepherd Dr Ste 100 · Houston, TX · 77007-1320
Is this the product you have?
- 3.5mm Aresenal Screw Drill Bit
- Ref330-35-001, Qty. 70, Rx Only, Non-Sterile
- UDI(01)00812926029696 -
- Product UsageA drill bit facilitates implant insertion
- Lot codes and dates
- Lot # TSL008495A
- Amount recalled
- 5 drill bits
Where it was sold
- Nationwide
- CA
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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