Zimmer Biomet Affixus Hip Nail Recall: Sterile Packaging Open in Surgery

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Recalling firmZimmer Biomet, Inc.56 E Bell Dr, N/A · 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 Affixus Hip Fracture Nails because the sterile packaging may be open during surgery. This could lead to infection risks if the device is not properly sterilized before use.

Why it’s dangerous

The sterile packaging being open during surgery means the device may not be properly sterilized. This could lead to infection if the device is used without being re-sterilized.

Who’s affected

Surgical teams using the recalled Affixus Hip Fracture Nails for hip fracture fixation are affected. Patients undergoing hip surgery with these specific lot numbers are at risk of infection.

How to tell if you have this one

Check the lot numbers on the packaging: 244100, 584910, or 616470. The product is an Affixus Hip Fracture Nail Right 125 with dimensions 9 mm x 340 mm.

Brand
Zimmer Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Packaging
Look for lot numbers 244100, 584910, or 616470 on the sterile packaging.

✎ GovInfoNow

Questions people ask

Is there a remedy for this recall?

The recall notice does not specify any remedy.

What lot numbers are affected?

Lot numbers 244100, 584910, and 616470.

How can I tell if I have the recalled product?

Check the lot numbers on the packaging: 244100, 584910, or 616470.

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-0126-2019 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0126-2019 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-0126-2019 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0126-2019 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 Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of

Recall notice