PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: February 9, 2022 Initiated: December 13, 2021 #Z-0556-2022

Product Description

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.

Details

Recalling Firm
FEMSelect Ltd
Units Affected
141 units
Distribution
US Nationwide distribution in the state of Georgia.
Location
Modi'in, N/A

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by FEMSelect Ltd. Units affected: 141 units.
Why was this product recalled? ▼
Certain lots may not have been packaged wth the Channel Tube Limiter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 9, 2022. Severity: Moderate. Recall number: Z-0556-2022.

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