# FDA recall Z-0301-2021

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2020-09-21.

## Product

5.5MM Arthrogarde Hip Access Cannula

## Reason for recall

The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.

## Distribution

Domestic Distribution: CA, CO, CT, GA, IA, IL, IN, MD, MO, NC, NY, OH, PA, SC, TN, TX, WA, WI, WV.    International Distribution: AU, BR, CA, CL, CN, CO, DE, ES, GB, HK, KR, PA, PT, TW.

## Key facts

- **Recall number:** Z-0301-2021
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-21
- **Report date:** 2020-11-04
- **Termination date:** 2024-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0301-2021

## Citation

> AI Analytics. FDA recall Z-0301-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0301-2021. Source: US FDA. Licensed CC0.

---

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