Z-1133-2023 Class II Ongoing
FDA device recall Z-1133-2023 was initiated by Conformis, Inc. on November 14, 2022 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 70.
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2023
- Initiation Date
- November 14, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70
Product Description
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Reason for Recall
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.
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.
Code Information
UDI-DI 00810933030582 Lot D221301