FDA-Device2020-01-01Class II
Lamicel 20PK 5MM INTL
Medtronic Xomed, Inc.
Hazard
Routine sterilization dose does not meet the required Sterility Assurance Level.
Sold states
Affected product was only distributed in Japan.
Affected count
307 packs; 6140 units
Manufactured in
6743 Southpoint Dr N, Jacksonville, FL, United States
Products
Lamicel 20PK 5MM INTL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0734-2020Don't want to check this manually?
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