Zimmer Biomet, Inc. recalls BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113…
- Recall date
- August 21, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0533-2020
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- 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.
Why it was recalled
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
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