Reported Nov 13, 2019 · Terminated

Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817…

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?

  • Trabecular Metal Reverse Shoulder System, Item Nos.

    68 of 68 codes

    • 00434210613
    • 00430900103
    • 00434210613
    • 00434210813
    • 00434210817
    • 00434210913
    • 00434211013
    • 00434211017
    • 00434211113
    • 00434211213
    • 00434211217
    • 00434211313
    • 00434211413
    • 00434211417
    • 00434211513
    • 00434211613
    • 00434211713
    • 00434211813
    • 00434810613
    • 00434810813
    • 00434810817
    • 00434810913
    • 00434811013
    • 00434811017
    • 00434811113
    • 00434811213
    • 00434811217
    • 00434811313
    • 00434811413
    • 00434811417
    • 00434811513
    • 00434811613
    • 00434811713
    • 00434811813
    • 00434900813
    • 00434900817
    • 00434901013
    • 00434901017
    • 00434901213
    • 00434901217
    • 00434901413
    • 00434903700
    • 00434903811
    • 00434903909
    • 00434903912
    • 32855090339
    • 32855090353
    • 32855090368
    • 32855090375
    • 32855090395
    • 32855090512
    • 32855090519
    • 32855090520
    • 32855090531
    • 32855090585
    • 32855090593
    • 32855090598
    • 32855090599
    • 32855090628
    • 32855090636
Lot codes and dates
  • All product manufactured prior to January 2014.
Amount recalled
5,459,583 total devices

This recall covers 41 products

The agency filed one notice per product. You are reading one of them; the other 40 are below.

28 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

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

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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 19, 2020 · Data as of Sep 19, 5:25 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.