Device product
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.
Z-1750-2020
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 85272
- Status
- Terminated
- Classification
- Class II
- Quantity
- 125
- Official record key
device-enforcement:Z-1750-2020
Official wording
Reason: There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
Code information: Lot Numbers: 494350 494350R 233080 364910 489000 079630 516230 742760 362370 465800 197900 175110 175100
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.
Derived failure modes
-
Unknown
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.