FDA recall Z-1133-2023

Product

iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

Reason for recall

Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.

Distribution

US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA, MA, MD, MS, NE, NH, NV, NY, OH, TN, WI, WY.

Key facts

Status

Ongoing

Initiation date

2022-11-14

Report date

2023-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1133-2023