Recall Z-0734-2020— Medtronic Xomed, Inc.

Name: FDA recall Z-0734-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-13

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 5MM INTL. 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 5MM INTL

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.