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Recall Observatory FDA recall evidence

Device product

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

Z-1133-2023

November 14, 2022

Class II

Product summary

Firm
Conformis, Inc.
Event
Event 91376
Status
Ongoing
Classification
Class II
Quantity
70
Official record key
device-enforcement:Z-1133-2023

Official wording

Reason: 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.

Code information: UDI-DI 00810933030582 Lot D221301

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.