# FDA recall Z-2849-2020

> **Conformis, Inc.** · Class II · device recall initiated 2020-07-20.

## Product

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant  Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

## Reason for recall

Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

## Distribution

NV

## Key facts

- **Recall number:** Z-2849-2020
- **Recalling firm:** Conformis, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-20
- **Report date:** 2020-09-02
- **Termination date:** 2021-06-21

- **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-2849-2020

## Citation

> AI Analytics. FDA recall Z-2849-2020. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-2849-2020. Source: US FDA. Licensed CC0.

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