Zimmer Biomet Affixus Hip Nail Recall: Set Screw Malfunction Risk

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Recalling firmZimmer Biomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Zimmer Biomet is recalling Affixus Hip Fracture Nails left deg 9x300mm (item 814609300) because the set screw can't move forward or backward properly. This could lead to improper fracture stabilization during surgery.

Why it’s dangerous

The set screw in the nail cannot advance or reverse from its original position. This may cause the nail to become stuck, potentially leading to improper fracture stabilization during surgery.

Who’s affected

Surgeons who used the Affixus Hip Fracture Nail System with item number 814609300 for hip fracture treatment. The risk is highest for those who have already implanted the device.

How to tell if you have this one

Check for the item number 814609300 on the Affixus Hip Fracture Nail Left Deg 9x300mm. The recall includes units with lot number 371540.

Brand
Zimmer Biomet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the item number on the nail is 814609300 and lot number 371540.

✎ GovInfoNow

Questions people ask

Is this recall for patients or surgeons?

This recall is for surgeons who used the Affixus Hip Fracture Nail System with item number 814609300 for hip fracture treatment.

What should I do if I have this product?

The official recall notice does not specify a remedy or action for affected units.

How can I tell if my nail is affected?

Check for item number 814609300 and lot number 371540 on the Affixus Hip Fracture Nail Left Deg 9x300mm.

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-0447-2019 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0447-2019 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-0447-2019 (October 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0447-2019 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 Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of

Lower-risk recall