Recall Z-1892-2020— Trilliant Surgical, LLC
Class II · Terminated
Class II FDA medical device recall by Trilliant Surgical, LLC, initiated 2019-10-10, terminated 2022-04-27. FDA's recall record names no specific 510(k) clearance for this event. 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 implant insertion. Reason: 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..
- Recalling firm
- Trilliant Surgical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-10
- Terminated
- 2022-04-27
- Firm location
- Houston, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.