FDA-Device2020-01-01Class II
Lamicel 10PK 10MM 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
10 packs; 100 units
Manufactured in
6743 Southpoint Dr N, Jacksonville, FL, United States
Products
Lamicel 10PK 10MM INTL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2020Don'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