# FDA recall Z-2077-2021

> **Axonics Modulation Technologies, Inc.** · Class II · device recall initiated 2021-06-03.

## Product

BULKAMID, URETHRAL BULKING SYSTEM model # 50050  containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

## Reason for recall

Lack of Sterility Assurance; needle in procedure pack labeled  as sterile may not have been adequately sterilized

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-2077-2021
- **Recalling firm:** Axonics Modulation Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-03
- **Report date:** 2021-07-21
- **Termination date:** 2022-04-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2021

## Citation

> AI Analytics. FDA recall Z-2077-2021. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-2077-2021. Source: US FDA. Licensed CC0.

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