Home / Recalls / Medtronic Xomed, Inc. / Z-0733-2020

Z-0733-2020 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
29320 units

Product Description

Lamicel 20PK 3MM INTL Cervical dilator

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: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438

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