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

Hazard

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.

Details from the source

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. Quantity: 70 Lot/code info: UDI-DI 00810933030582 Lot D221301

UPC codes

00810933030582

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.