Zimmer Biomet Microfixation RapidFlap System Recall: Incorrect Assembly Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Zimmer Biomet is recalling 12-pack RapidFlap SpinDown Clamps that may have been assembled incorrectly. This could lead to improper bone flap reattachment during surgery, potentially causing complications.

Why it’s dangerous

The spin-down nut interfaces with the outer plate incorrectly, which could cause improper bone flap reattachment during surgery. This might lead to surgical complications if the clamp fails to hold the bone flap securely.

Who’s affected

Surgical teams using the 12-pack RapidFlap SpinDown Clamps with ref number 75-1020-12 for cranial procedures are most at risk. Patients undergoing surgery with these clamps may face complications.

How to tell if you have this one

Check for the product name 'Biomet Microfixation RapidFlap System', 12MM SpinDown Clamp, 12-pack, and reference number 75-1020-12. Units expired before September 18, 2023, are affected.

Brand
Zimmer Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the reference number 75-1020-12 and expiration date before September 18, 2023.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the clamps may have been assembled incorrectly, which could lead to surgical complications. Affected units should not be used.

What is the reference number for the affected product?

The reference number is 75-1020-12.

When was the product expired?

The product expired before September 18, 2023.

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-0394-2019 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0394-2019 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-0394-2019 (August 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0394-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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 Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the

Use caution until it’s fixed