Reported Apr 29, 2020 · Terminated

Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended…

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: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips
  • Model Number 110028522 - Product UsageIntended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint
Lot codes and dates
  • Lot Numbers
    • 494350
    • 494350R
    • 233080
    • 364910
    • 489000
    • 079630
    • 516230
    • 742760
    • 362370
    • 465800
    • 197900
    • 175110
    • 175100
Amount recalled
125

Where it was sold

Why it was recalled

There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.

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 Jul 21, 2021 · 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.