Reported Oct 24, 2018 · Terminated

Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of…

Zimmer Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • Affixus Hip Fracture Nail Right 125 11 mm x 340 mm
  • Item Number 814311340 Product UsageIntended for the fixation of fractures
Lot codes and dates
  • Lot Numbers244090 288670
Amount recalled
27

This recall covers 48 products

The agency filed one notice per product. You are reading one of them; the other 47 are below.

35 more are in the archive.

Where it was sold

Why it was recalled

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 30, 2020 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.