Zimmer Biomet Affixus Hip Fracture Nail Recall: Set Screw Malfunction

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Recalling firmZimmer Biomet, Inc.56 E Bell Dr · 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 have a set screw which cannot advance or reverse from its original position. This could lead to improper fixation of the hip fracture, potentially causing complications during surgery or after the procedure.

Why it’s dangerous

The set screw in the nail fails to move forward or backward from its starting position. This could cause the nail to become improperly secured during surgery, potentially leading to instability in the hip fracture fix.

Who’s affected

Surgeons who use the Affixus Hip Fracture Nail System (Item 816810165) with lot numbers 558260 or 558270 are affected. The risk is primarily for medical professionals performing hip fracture repairs.

How to tell if you have this one

Check for the product name 'Affixus Hip Fracture Nail 130 Deg 10x165mm' with item number 816810165. Affected units were sold with lot numbers 558260 or 558270.

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 numbers 558260 or 558270 on the packaging or device.

✎ GovInfoNow

Questions people ask

Why is this nail being recalled?

The set screw cannot advance or reverse from its original position, which may cause improper fixation of the hip fracture.

What should I do if I have this product?

Check the lot number on the packaging or device. If it is 558260 or 558270, contact Zimmer Biomet for further instructions.

Is there a fix for this issue?

The recall record does not mention a remedy or fix for this issue.

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-0453-2019 — Zimmer Biomet Zimmer Biomet

Hello,

I own a Zimmer Biomet that is covered by recall Z-0453-2019 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-0453-2019 (October 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0453-2019 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 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of

Lower-risk recall