FDA-Device2017-02-22Class I
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Zimmer Biomet, Inc.
Hazard
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
Sold states
Nationwide. CANADA AUSTRALIA CHILE COLOMBIA KOREA Netherlands
Affected count
4388
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1103-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief