# FDA recall Z-1627-2020

> **Conformis, Inc.** · Class II · device recall initiated 2020-02-03.

## Product

iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

## Reason for recall

A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

## Distribution

US Nationwide distribution in the states of LA, NY, TN.

## Key facts

- **Recall number:** Z-1627-2020
- **Recalling firm:** Conformis, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-03
- **Report date:** 2020-04-08
- **Termination date:** 2020-12-02

- **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-1627-2020

## Citation

> AI Analytics. FDA recall Z-1627-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1627-2020. Source: US FDA. Licensed CC0.

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