Device 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
Z-1892-2020
Product summary
- Event
- Event 85374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 drill bits
- Official record key
device-enforcement:Z-1892-2020
Official wording
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.
Code information: Lot # TSL008495A
Distribution pattern: US Nationwide distribution in the state of CA. OUS: None
Derived failure modes
-
Labeling or packaging
Labeling Error