FDA recall Z-0735-2020
Medtronic Xomed, Inc. · Class II · device
Product
Lamicel 10PK 10MM INTL
Reason for recall
Routine sterilization dose does not meet the required Sterility Assurance Level.
Distribution
Affected product was only distributed in Japan.
Key facts
- Status
- Ongoing
- Initiation date
- 2019-11-13
- Report date
- 2020-01-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Jacksonville, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2020