Device product

Lamicel 20PK 5MM INTL

Z-0734-2020

November 13, 2019

Class II

Product summary

Firm: Medtronic Xomed, Inc.
Event: Event 84332
Status: Ongoing
Classification: Class II
Quantity: 307 packs; 6140 units
Official record key: device-enforcement:Z-0734-2020

Official wording

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

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

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.