Reported Jan 16, 2013 · Terminated

PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained,…

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?

  • PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Lot codes and dates
    • Part 113950 Lot 093540
    • 093550
    • 093570
    • 093580
    • 093590
    • 093600
    • 093610
    • 093620
    • 093720
    • 093730
    • 093740
    • 093760
    • 093770
    • 093780
    • 282590
    • 282600
    • 282620
    • 282630
    • 282680
    • 282700
    • 282710
    • 489160
    • 489180
    • 489200
    • 489210
    • 489770
    • 489780
    • 489790
    • 714480
    • 714550
    • 714570
    • 714700
    • 714730
    • 722210
    • 722250
    • 722280
    • 984770
    • 984780
    • 984790
    • 984800
    • 984810
    • 984820
    • 984830
    • 984840
    • and 984850
Amount recalled
1050

Where it was sold

  • Nationwide

Why it was recalled

Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be prese

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 Nov 8, 2013 · Data as of Sep 19, 4:48 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.