Unrated Medical device recall · FDA · Published September 30, 2020

Merz COAPTITE Injectable Implant Recall: IFU Mismatch Risk

Merz recalls COAPTITE Injectable Implant (model M0068903000) due to updated Instructions for Use not matching post-approval study data. Affected lots: 100127846-100129615.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0401-2021Medical device Merz ›

Recall notice

The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/64135-merz-coaptite-injectable-implant-recall-ifu-mismatch-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64135-merz-coaptite-injectable-implant-recall-ifu-mismatch-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0401-2021

Cite this page

“Merz COAPTITE Injectable Implant Recall: IFU Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64135-merz-coaptite-injectable-implant-recall-ifu-mismatch-risk. Based on FDA recall #Z-0401-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0401-2021%22&limit=1).

The FDA announced on September 30, 2020, that Merz North America, Inc. is recalling the COAPTITE Injectable Implant because the Instructions for Use do not match post-approval study data. The recall affects 2,051 units distributed across the United States.

How to tell if you have it

Brand: Merz
Product: COAPTITE Injectable Implant
Model: M0068903000
Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615

The hazard

According to the FDA, the hazard is that the Instructions for Use updated on March 2, 2020, does not match data listed in the post-approval study.

Context

GovInfoNow's records show Merz has been involved in other recent recalls of similar products, including a COAPTI medical device shelf life recall reported on June 15, 2026. Other recent recalls of similar products include an Arrowhead Implant recall for potential infection risk from sterility issues (June 23, 2026) and a Straumann GM Helix Dental Implant recall for packaging mismatch risk (July 13, 2026).

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.

Where it went and when

Where it was distributed

Distributed in 47 states and D.C..

FDA distribution: “US only distribution - AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 56 days after the firm started it.

Sep 30, 2020Firm started the recall
Nov 16, 2020FDA classified it Class II
Nov 25, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64135-merz-coaptite-injectable-implant-recall-ifu-mismatch-risk">Merz COAPTITE Injectable Implant Recall: IFU Mismatch Risk (GovInfoNow)</a>

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.