Z-1892-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- October 10, 2019
- Termination Date
- April 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 drill bits
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.
Distribution Pattern
US Nationwide distribution in the state of CA. OUS: None
Code Information
Lot # TSL008495A