FDA recall Z-1366-2022

Product

Wright EVOLVE TRIAD Plate Cutter, REF 49510120

Reason for recall

The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use

Distribution

Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico

Key facts

Status

Ongoing

Initiation date

2022-06-14

Report date

2022-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1366-2022