# FDA recall Z-1608-2024

> **Zimmer, Inc.** · Class II · device recall initiated 2024-03-28.

## Product

NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.

## Reason for recall

Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.

## Distribution

Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands.

## Key facts

- **Recall number:** Z-1608-2024
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-28
- **Report date:** 2024-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1608-2024

## Citation

> AI Analytics. FDA recall Z-1608-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1608-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*