# FDA recall Z-1103-2021

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2021-01-08.

## Product

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

## Reason for recall

The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of  AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.

## Key facts

- **Recall number:** Z-1103-2021
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-08
- **Report date:** 2021-02-17
- **Termination date:** 2024-01-17

- **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-1103-2021

## Citation

> AI Analytics. FDA recall Z-1103-2021. Retrieved 2026-09-16 from https://api.ai-analytics.org/recall/Z-1103-2021. Source: US FDA. Licensed CC0.

---

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