Zimmer Biomet Comprehensive RS Cleat CAP Recall: Bacterial Endotoxin Risk

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Contact the company & request your remedy

Recalling firmZimmer Biomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Zimmer Biomet is recalling certain Comprehensive RS Cleat CAPs because cleaning issues left bacterial endotoxins and debris on the devices. This could increase infection risk during medical procedures if the device is used without proper cleaning.

Why it’s dangerous

The devices contain elevated bacterial endotoxin and residual debris due to a cleaning issue. This can lead to infections if the device is used in medical procedures without proper cleaning.

Who’s affected

Medical professionals using the recalled Comprehensive RS Cleat CAPs for surgical procedures are most at risk. Patients receiving these devices during surgery could face infection risks.

How to tell if you have this one

Check for the item numbers 110300, 126590, 12660: 126600, 502890, 502900, 502910, 012080, 941080 on the device packaging or label.

Brand
Zimmer Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Label
Look for the item numbers 110300, 126590, 126600, 502890, 502900, 502910, 012080, or 941080 on the device packaging or label.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to elevated bacterial endotoxin and residual debris remaining on the devices from a cleaning issue.

How can I tell if I have a recalled device?

Check for the item numbers 110300, 126590, 126600, 502890, 502900, 502910, 012080, or 941080 on the device packaging or label.

What should I do if I have a recalled device?

The recall record does not specify a remedy, so contact Zimmer Biomet directly for guidance.

Take action

Contact Zimmer Biomet

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

✉️ Open in email

Subject: Recall Z-0525-2020 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0525-2020 from Zimmer Biomet.

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-0525-2020 (August 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0525-2020 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.

Zimmer Biomet, Inc. recalls Comprehensive RS Cleat CAP, Item No. 110300

Lower-risk recall