Home / Recalls / Medtronic Xomed, Inc. / Z-0734-2020

Z-0734-2020 Class II Ongoing

Recalled by Medtronic Xomed, Inc. — Jacksonville, FL

Recall Details

Product Type
Devices
Report Date
January 1, 2020
Initiation Date
November 13, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
307 packs; 6140 units

Product Description

Lamicel 20PK 5MM INTL

Reason for Recall

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

Distribution Pattern

Affected product was only distributed in Japan.

Code Information

UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918

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