Biomet RapidFire Clip Recall: Risk of Sterility Loss in Craniofacial Surgery

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Recalling firmBiomet, Inc.56 E Bell Dr, N/A · Warsaw, IN 46582-6989

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Biomet is recalling specific lots of RapidFire Clip devices used for craniofacial bone fixation because some packaging may have been compromised, risking loss of sterility during surgery. This could lead to infections or other complications if the device is not properly sterile.

Why it’s dangerous

The packaging seal on certain lots may be breached, which could allow contamination of the sterile device. If the device is not sterile, it could lead to infections or complications during surgery.

Who’s affected

Surgical patients and medical professionals using the RapidFire Clip for craniofacial bone fixation. Those with the specific lot numbers listed are most at risk.

How to tell if you have this one

Check the lot numbers on the device: 080580, 231760, 359160, 359170, 381910, 382870, 382900, 382970, or 383010. The device is used for fixing craniofacial bone in surgical procedures.

Brand
Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for the lot numbers listed: 080580, 231760, 359160, 359170, 381910, 382870, 382900, 382970, or 383010.

✎ GovInfoNow

Questions people ask

What is the RapidFire Clip used for?

The RapidFire Clip is used for fixation of craniofacial bone in surgical procedures.

Which lot numbers are affected?

Lots 080580, 231760, 359160, 359170, 381910, 382870, 382900, 382970, and 383010.

Is there a remedy for this recall?

The recall record does not specify a remedy.

Take action

Contact Biomet

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

✉️ Open in email

Subject: Recall Z-0626-2021 — Biomet Biomet

Hello,

I own a Biomet that is covered by recall Z-0626-2021 from 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-0626-2021 (November 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0626-2021 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.

Biomet, Inc. recalls RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.

Lower-risk recall