PlainRecalls
FDA Devices Moderate Class II Ongoing

Lamicel 10PK 10MM INTL

Reported: January 1, 2020 Initiated: November 13, 2019 #Z-0735-2020

Product Description

Lamicel 10PK 10MM INTL

Reason for Recall

Routine sterilization dose does not meet the required Sterility Assurance Level.

Details

Recalling Firm
Medtronic Xomed, Inc.
Units Affected
10 packs; 100 units
Distribution
Affected product was only distributed in Japan.
Location
Jacksonville, FL

Frequently Asked Questions

What product was recalled?
Lamicel 10PK 10MM INTL. Recalled by Medtronic Xomed, Inc.. Units affected: 10 packs; 100 units.
Why was this product recalled?
Routine sterilization dose does not meet the required Sterility Assurance Level.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 1, 2020. Severity: Moderate. Recall number: Z-0735-2020.