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Recall Observatory FDA recall evidence

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

March 13, 2020

Class II

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

    reason.no_named_rule · v1.0.0

    There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.