Reported Jan 19, 2022 · Terminated

GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

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 12 Product Code110012100
Lot codes and dates
  • 113 of 113 codes

    • Lot #: 9793650
    • 9793651
    • 9793652
    • 9802212
    • 9802213
    • 9802214
    • 9802215
    • 9802216
    • 9802217
    • 9802218
    • 9802219
    • 9802220
    • 9802221
    • 9802222
    • 9802223
    • 9802224
    • 9802225
    • 9802226
    • 9802227
    • 9802228
    • 9802229
    • 9802230
    • 9802231
    • 9802232
    • 9802233
    • 9802234
    • 9802235
    • 9802236
    • 9802237
    • 9802238
    • 9802239
    • 9802240
    • 9802241
    • 9802242
    • 9802243
    • 9802244
    • 9802245
    • 9802246
    • 9802249
    • 9802250
    • 9802251
    • 9802253
    • 9802254
    • 9802255
    • 9802256
    • 9802257
    • 9802258
    • 9802259
    • 9824440
    • 9824441
    • 9824442
    • 9824443
    • 9824445
    • 9824446
    • 9824447
    • 9824448
    • 9824449
    • 9824450
    • 9824451
    • 9824457
  • GTIN10603295004127
Amount recalled
870 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, 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.