FDA-Device2023-02-22Class II
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Conformis, Inc.
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.
Sold states
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.
Affected count
70
Manufactured in
600 Technology Park Dr Ste 3, N/A, Billerica, MA, United States
Products
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1133-2023Don't want to check this manually?
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