FEMSelect EnPlace Pelvic Floor Repair System Recall: Missing Channel Tube Limiter

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Recalling firmFEMSelect LtdHaMa'ayan 2, First Floor · Modi'in, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

FEMSelect is recalling two specific lots of their EnPlace single-use pelvic floor repair system because some units might not have the Channel Tube Limiter included. This could lead to improper surgical handling during procedures.

Why it’s dangerous

The Channel Tube Limiter is a critical component that guides the device during surgery. Without it, the surgeon might not handle the device correctly, potentially causing complications.

Who’s affected

Surgical patients and healthcare providers using the EnPlace system. Those who received the specific lot numbers 21072510 or 21072512 are most at risk.

How to tell if you have this one

Check the lot numbers on the packaging: 21072510 or 21072512. The EnPlace system is a single-use trans-vaginal pelvic floor repair device sold for surgical use.

Brand
FEMSelect
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 21072510 or 21072512 on the packaging.

✎ GovInfoNow

Questions people ask

What is the EnPlace system used for?

The EnPlace system is a single-use trans-vaginal pelvic floor repair device for attaching sutures to pelvic ligaments during surgery.

Which lot numbers are affected?

Lot numbers 21072510 and 21072512 are affected by this recall.

Is there a remedy for this issue?

The recall record does not specify a remedy, so no action is required beyond checking the lot number.

Take action

Contact FEMSelect

We’ve drafted a message you can send FEMSelect to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0556-2022 — FEMSelect FEMSelect

Hello,

I own a FEMSelect that is covered by recall Z-0556-2022 from FEMSelect.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0556-2022 (December 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0556-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

FEMSelect Ltd recalls The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the

Lower-risk recall