Reported Mar 2, 2016 · Terminated

HipLOC CHS Plate/Lag Screw Introducer

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?

  • HipLOC CHS Plate/Lag Screw Introducer
Lot codes and dates
  • Catalog Number35-000263
  • and Lot Number Identification
    • 1807188
    • 1807189
    • 1943563
    • and 2577847
Amount recalled
23 units

Where it was sold

Why it was recalled

A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.

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 Feb 14, 2017 · Data as of Sep 19, 6:00 PM UTC

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