Device product
Lamicel 10PK 10MM INTL
Z-0735-2020
Product summary
- Event
- Event 84332
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 packs; 100 units
- Official record key
device-enforcement:Z-0735-2020
Official wording
Reason: Routine sterilization dose does not meet the required Sterility Assurance Level.
Code information: UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170
Distribution pattern: Affected product was only distributed in Japan.
Derived failure modes
-
Unknown
Routine sterilization dose does not meet the required Sterility Assurance Level.