Merz COAPTITE Injectable Implant Recall: IFU Mismatch Risk

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Recalling firmMerz North America, Inc.4133 Courtney Rd Ste 10, N/A · Franksville, WI 53126-9127

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Merz is recalling COAPTITE Injectable Implant products because the updated Instructions for Use (IFU) from March 2020 don't match the data from their post-approval study. This mismatch could affect how the product is used safely.

Why it’s dangerous

The product's Instructions for Use were updated on March 2, 2020, but these updated instructions don't match the data from the product's post-approval study. This mismatch could lead to incorrect usage or safety issues during medical procedures.

Who’s affected

Patients who received the recalled COAPTITE Injectable Implant (model M0068903000) during procedures between specific production lots. Medical professionals using the product for injections are most at risk.

How to tell if you have this one

Check if your COAPTITE Injectable Implant has model number M0068903000 and production lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, or 100129615.

Brand
Merz
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if your COAPTITE Injectable Implant has model M0068903000 and the listed production lots.

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Questions people ask

Why is this product being recalled?

The updated Instructions for Use (IFU) from March 2, 2020 do not match the data listed in the post-approval study.

What model numbers are affected?

Model M0068903000 with production lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615.

What should I do if I have this product?

The recall record does not specify a remedy, so check with Merz North America, Inc. for further instructions.

Take action

Contact Merz

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

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Subject: Recall Z-0401-2021 — Merz Merz

Hello,

I own a Merz that is covered by recall Z-0401-2021 from Merz.

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-0401-2021 (September 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0401-2021 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.

Merz North America, Inc. recalls COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns

Recall notice