Z-1750-2020 Class II Terminated
FDA device recall Z-1750-2020 was initiated by Biomet, Inc. on March 13, 2020 and is designated Class II. Reason for recall: There were unknown bioburden levels prior to sterilization, which may affect sterility of the product. The recall status is terminated (terminated July 21, 2021). Affected quantity: 125.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- March 13, 2020
- Termination Date
- July 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125
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.
Distribution Pattern
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.
Code Information
Lot Numbers: 494350 494350R 233080 364910 489000 079630 516230 742760 362370 465800 197900 175110 175100