3.5mm Aresenal Screw Drill Bit recall: Labeling Error
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…
Why was 3.5mm Aresenal Screw Drill Bit 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # TSL008495A
- 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…
- Recalling firm
- Trilliant Surgical, LLC
- Quantity
- 5 drill bits
- Distribution
- US Nationwide distribution in the state of CA. OUS: None
- Recall date
- May 13, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)