Reported Apr 25, 2018 · Terminated

Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is…

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. · 1800 W Center St · Warsaw, IN · 46580-2304

Is this the product you have?

  • Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
Lot codes and dates
  • 328 of 328 codes

    • 11002427
    • 11004885
    • 11005449
    • 11006334
    • 11006335
    • 11008928
    • 61369868
    • 61369869
    • 61399454
    • 61399456
    • 61402368
    • 61427788
    • 61427789
    • 61427790
    • 61532231
    • 61532232
    • 61532233
    • 61532234
    • 61532235
    • 61532236
    • 61532237
    • 61532238
    • 61532239
    • 61532241
    • 61551139
    • 61551140
    • 61551141
    • 61636762
    • 61646779
    • 61651745
    • 61673447
    • 61711591
    • 61718216
    • 61730528
    • 61736057
    • 61754485
    • 61765397
    • 61771371
    • 61774299
    • 61853520
    • 61858613
    • 61863256
    • 61863257
    • 61872494
    • 61872495
    • 61877127
    • 61881912
    • 61881913
    • 61886497
    • 61890895
    • 61890896
    • 61890897
    • 61896238
    • 61906572
    • 61932477
    • 61938143
    • 61948661
    • 61948662
    • 61948663
    • 61948664
Amount recalled
1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf

Where it was sold

Why it was recalled

There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.

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 Dec 17, 2019 · Data as of Sep 19, 5:32 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.