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
Reported: May 13, 2020 Initiated: October 10, 2019 #Z-1892-2020
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Trilliant Surgical, LLC
- Units Affected
- 5 drill bits
- Distribution
- US Nationwide distribution in the state of CA. OUS: None
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Trilliant Surgical, LLC. Units affected: 5 drill bits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1892-2020.
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