# FDA recall Z-0899-2022

> **Conformis, Inc.** · Class II · device recall initiated 2022-02-22.

## Product

iTotal Identity Posterior Stabilised (PS) Knee Replacement System  Model Number: TPS-301-1113-020101

## Reason for recall

Incorrect tibial base plate implant packaged in kit

## Distribution

MS

## Key facts

- **Recall number:** Z-0899-2022
- **Recalling firm:** Conformis, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-02-22
- **Report date:** 2022-04-20

- **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-0899-2022

## Citation

> AI Analytics. FDA recall Z-0899-2022. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0899-2022. Source: US FDA. Licensed CC0.

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