FDA recall Z-1216-2022

Product

Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

Reason for recall

The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2022-05-03

Report date

2022-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2022