FDA recall Z-1750-2020

Biomet, Inc. · Class II · 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.

Reason for recall

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

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.

Key facts

Status
Terminated
Initiation date
2020-03-13
Report date
2020-04-29
Termination date
2021-07-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1750-2020