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

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✎ 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.

Who’s affected

Surgical teams using the Affixus Hip Fracture Nail Right 130 model with lot number 343630 are affected. Patients undergoing hip fracture surgery are at risk of infection if the product is not properly sterile.

How to tell if you have this one

Check for the product name 'Affixus Hip Fracture Nail Right 130' with item number 814511400. Lot number 343630 is the affected batch.

Brand
Zimmer Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot number 343630 on the packaging to confirm if the product is affected.

✎ GovInfoNow

Questions people ask

Is there a fix for this issue?

The recall notice does not specify any remedy or fix for this issue.

How can I tell if my product is affected?

Check for lot number 343630 on the packaging of Affixus Hip Fracture Nail Right 130 with item number 814511400.

What should I do if I have this product?

The recall notice does not specify any action steps for affected products.

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-0162-2019 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0162-2019 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-0162-2019 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0162-2019 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 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of

Lower-risk recall