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Conformis, Inc. recalls iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Recalled February 22, 2023 · FDA recall Z-1133-2023 · Conformis
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. · FDA Class II
Units
70
Sold at
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.
Description
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.
Product
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Manufacturer(s)
Conformis, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →