FDA recall Z-0733-2020
Medtronic Xomed, Inc. · Class II · device
Product
Lamicel 20PK 3MM INTL Cervical dilator
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-0733-2020