FDAFDA · Food and drugs·Recall number Z-1750-2020
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended 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.
Published April 29, 2020 · Recall initiated: March 13, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Worldwide distribution - US Nationwide distribution including the states of AL, CO, KS, MA, MD, MI, MO, NH, NJ, and PA. The countries of Australia, Canada, India, and Netherlands.
- Lot
- Lot Numbers: 494350 494350R 233080 364910 489000 079630 516230 742760 362370 465800 197900 175110 175100
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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