Device product

Lamicel 20PK 3MM INTL Cervical dilator

Z-0733-2020

November 13, 2019

Class II

Product summary

Firm: Medtronic Xomed, Inc.
Event: Event 84332
Status: Ongoing
Classification: Class II
Quantity: 29320 units
Official record key: device-enforcement:Z-0733-2020

Official wording

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

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

Distribution pattern: Affected product was only distributed in Japan.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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