Zimmer Biomet Recall: Incorrectly Assembled SpinDown Clamp Risk

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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 12-pack of 20MM RapidFlap SpinDown Clamps because they were assembled incorrectly. This could lead to failure during surgery, which is serious for patients needing brain surgery.

Why it’s dangerous

The SpinDown RapidFlap nut interfaces with the outer plate incorrectly. This could cause the clamp to fail during surgery, potentially leading to complications like bleeding or improper bone flap reattachment.

Who’s affected

Surgical teams using the Biomet Microfixation RapidFlap System for brain surgery are affected. Patients undergoing craniotomy procedures are at risk if the clamp fails during surgery.

How to tell if you have this one

Check for the 12-pack of 2: 20MM RapidFlap SpinDown Clamps with reference number 75-1040-12. The product was sold before September 18, 2023, with an expiry date before that date.

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 75-1040-12 and that the product was sold before September 18, 2023.

✎ GovInfoNow

Questions people ask

Is this product used in brain surgery?

Yes, this product is used for re-attaching bone flaps after a craniotomy.

What is the risk of using this product?

The SpinDown RapidFlap nut interfaces with the outer plate incorrectly, which could cause failure during surgery.

How can I check if I have the recalled product?

Look for the 12-pack of 20MM RapidFlap SpinDown Clamps with reference number 75-1040-12 that were sold 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-0398-2019 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0398-2019 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-0398-2019 (August 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0398-2019 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 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the

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