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 hip fracture nails that may have open sterile packaging during surgery. This could lead to infection risks if the product is used without proper sterility.

Why it’s dangerous

The sterile packaging may be open before surgery, which could lead to contamination. This risk occurs if the product is used without proper sterility checks during the surgical procedure.

Who’s affected

Orthopedic surgeons and hospitals using the Affixus Hip Fracture Nail Right 125 model with lot number 343500 are affected. Patients receiving this specific surgical implant are at risk of infection.

How to tell if you have this one

Check for the product name 'Affixus Hip Fracture Nail Right 125', item number 814313260, and lot number 343500. This product was sold for surgical use.

Brand
Zimmer Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Sterile Packaging
Verify if the sterile packaging is open before surgery. If open, do not use the product.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product may have open sterile packaging during surgery, which could lead to infection risks. Do not use if packaging is open.

What lot number is affected?

Lot number 343500 is affected.

How can I get a replacement?

The recall record does not specify replacement options. Contact Zimmer Biomet directly for instructions.

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-0139-2019 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0139-2019 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-0139-2019 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0139-2019 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 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of

Lower-risk recall