# FDA recall Z-1079-2019

> **Conformis, Inc.** · Class II · device recall initiated 2019-01-04.

## Product

iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

## Reason for recall

The labeling of the boxes and sterile pouches did not match the contents.

## Distribution

The products were distributed to the following US states: NH.    The products were distributed to the following foreign countries: Germany

## Key facts

- **Recall number:** Z-1079-2019
- **Recalling firm:** Conformis, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-04
- **Report date:** 2019-04-10
- **Termination date:** 2020-06-29

- **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-1079-2019

## Citation

> AI Analytics. FDA recall Z-1079-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1079-2019. Source: US FDA. Licensed CC0.

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