Reported Jan 19, 2022 · Terminated

GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

DePuy Orthopaedics, 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: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994

Is this the product you have?

  • GLOBAL
  • UNITE STD STEM SZ 16 Product Code110016100
Lot codes and dates
    • Lot #: 9793946
    • 9793947
    • 9802315
    • 9802316
    • 9802317
    • 9802318
    • 9802320
    • 9813856
    • 9814516
    • 9824502
    • 9824503
    • 9824505
    • 9834401
    • 9834402
    • 9836078
    • 9841198
    • 9880972
    • 9886688
    • 9887451
    • 9887452
  • GTIN10603295004189
Amount recalled
140 units

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 17, 2024 · Data as of Sep 19, 6:17 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.