# FDA recall Z-1591-2024

> **Conformis, Inc.** · Class II · device recall initiated 2024-03-11.

## Product

Identity Imprint PS Tibial Tray Size 4: Lot 540287

## Reason for recall

Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

## Distribution

US Nationwide distribution in the states of FL, KS and NH.

## Key facts

- **Recall number:** Z-1591-2024
- **Recalling firm:** Conformis, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-11
- **Report date:** 2024-04-24

- **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-1591-2024

## Citation

> AI Analytics. FDA recall Z-1591-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1591-2024. Source: US FDA. Licensed CC0.

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