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Zimmer Biomet, Inc. recalls BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418
Recalled December 4, 2019 · FDA recall Z-0533-2020 · Zimmer Biomet
Hazard
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. · FDA Class II
Units
214741
Sold at
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.
Description
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Product
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →