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FDANovember 14, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

conformis

UPCs

00810933030582

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE — Recall Details · AllClear