# FDA recall Z-0556-2022

> **FEMSelect Ltd** · Class II · device recall initiated 2021-12-13.

## Product

The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity.   The anchors are pre-loaded inside the device shaft and are ready for use.   A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace.   Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.

## Reason for recall

Certain lots may not have been packaged wth the Channel Tube Limiter.

## Distribution

US Nationwide distribution in the state of Georgia.

## Key facts

- **Recall number:** Z-0556-2022
- **Recalling firm:** FEMSelect Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-13
- **Report date:** 2022-02-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Modi'in, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0556-2022

## Citation

> AI Analytics. FDA recall Z-0556-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0556-2022. Source: US FDA. Licensed CC0.

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