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.
Reported: April 29, 2020 Initiated: March 13, 2020 #Z-1750-2020
Product Description
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.
Reason for Recall
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 125
- Distribution
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet, Inc.. Units affected: 125.
Why was this product recalled? ▼
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1750-2020.
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