Reported Nov 13, 2019 · Terminated

Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400…

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?

  • Various Surgical InstrumentsScrews and Reamers, Item Nos.
    • 00579104100
    • 00579104200
    • 00579104300
    • 00579104400
    • 00579105400
    • 00597909526
    • 00597909529
    • 00597909532
    • 00597909535
    • 00597909538
    • 00597909541
    • 00597909546
    • 00597909551
    • 00598304027
    • 00598304033
    • 00598304048
    • 00598304148
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, 5:30 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.