Device product
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Z-1133-2023
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
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.