Recall Z-0733-2020— Medtronic Xomed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Xomed, Inc., initiated 2019-11-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Lamicel 20PK 3MM INTL Cervical dilator. Reason: Routine sterilization dose does not meet the required Sterility Assurance Level..
- Recalling firm
- Medtronic Xomed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-11-13
- Firm location
- Jacksonville, FL, United States
Product description
Lamicel 20PK 3MM INTL Cervical dilator
Reason for recall
Routine sterilization dose does not meet the required Sterility Assurance Level.
Data sourced from openFDA. This site is unofficial and independent of the FDA.