FDA-Device2020-04-29Class II
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.
Biomet, Inc.
Hazard
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
Sold states
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.
Affected count
125
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1750-2020Don't want to check this manually?
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