Conformis, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1133-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 14, 2022

Date Posted: February 22, 2023

Recall Number: Z-1133-2023

Event ID: 91376

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.

Status: Ongoing

Product Quantity: 70

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.

Voluntary or Mandated:

Voluntary: Firm initiated