FDA-Device2019-12-04Class II
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
Zimmer Biomet, Inc.
Hazard
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Sold states
US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
Affected count
214741
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0533-2020Don't want to check this manually?
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