Reported Apr 1, 2020 · Terminated

Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the…

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 Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 -
  • Product UsageThe intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system
Lot codes and dates
  • Lot No. 659260
  • UDI Number(1)00880304462649(17)290814(10)659260
Amount recalled
14 units

Why it was recalled

A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

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 May 31, 2022 · Data as of Sep 19, 5:39 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.