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 increases the risk of infection for patients during the procedure.

Who’s affected

Surgical teams using the Affixus Hip Fracture Nail Right 125 (13 mm x 400 mm) with lot number 584890 are affected. Patients undergoing hip fracture surgery are at risk if the packaging was already open.

How to tell if you have this one

Check for the product name 'Affixus Hip Fracture Nail Right 125' with item number 814313400. Lot number 584890 is the affected batch.

Brand
Zimmer Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

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

✎ GovInfoNow

Questions people ask

Is there a fix for this issue?

The recall notice does not specify any remedy or fix.

Which lot numbers are affected?

Lot number 584890 is affected.

How can I tell if I have the recalled product?

Look for the product name 'Affixus Hip Fracture Nail Right 125' with item number 814313400 and lot number 584890.

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-0143-2019 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0143-2019 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-0143-2019 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0143-2019 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 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of

Recall notice