Zimmer Biomet Recall: Incorrectly Assembled SpinDown Clamps Risk Injury

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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 12-pack of 16MM RapidFlap SpinDown Clamps because they were assembled incorrectly. This could lead to injury during surgical procedures if the clamps fail to hold properly.

Why it’s dangerous

The SpinDown RapidFlap nut interfaces with the outer plate incorrectly, which could cause the clamp to fail during surgery. This might lead to improper bone flap reattachment and potential injury to the patient.

Who’s affected

Surgical teams using these clamps for bone flap reattachment after craniotomy are most at risk. Patients undergoing surgery with this specific product may be affected.

How to tell if you have this one

Check for the product name '16MM RapidFlap SpinDown Clamp, 12 Pack' with reference number 75-1030-12. Units were sold before the lot expiry date of 09/18/2023.

Brand
Zimmer Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name and reference number on the packaging to confirm if it matches the recalled item.
Contact Manufacturer
Reach out to Zimmer Biomet directly for further guidance on the recall process.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

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

What is the lot expiry date for affected units?

Affected units have a lot expiry date before 09/18/2023.

How can I tell if I have the recalled product?

Look for the product name '16MM RapidFlap SpinDown Clamp, 12 Pack' with reference number 75-1030-12.

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-0396-2019 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0396-2019 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-0396-2019 (August 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0396-2019 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 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the

Use caution until it’s fixed