# FDA recall Z-2405-2023

> **Conformis, Inc.** · Class II · device recall initiated 2023-06-16.

## Product

CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

## Reason for recall

30mm screws were labeled as 25mm screws.

## Distribution

US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.

## Key facts

- **Recall number:** Z-2405-2023
- **Recalling firm:** Conformis, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-16
- **Report date:** 2023-08-23

- **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-2405-2023

## Citation

> AI Analytics. FDA recall Z-2405-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2405-2023. Source: US FDA. Licensed CC0.

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