# FDA recall Z-1133-2023

> **Conformis, Inc.** · Class II · device recall initiated 2022-11-14.

## Product

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

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.

## Key facts

- **Recall number:** Z-1133-2023
- **Recalling firm:** Conformis, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-14
- **Report date:** 2023-02-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1133-2023

## Citation

> AI Analytics. FDA recall Z-1133-2023. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1133-2023. Source: US FDA. Licensed CC0.

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