FDA recall Z-1892-2020

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 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

US Nationwide distribution in the state of CA. OUS: None

Key facts

Status

Terminated

Initiation date

2019-10-10

Report date

2020-05-13

Termination date

2022-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2020