Device product
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Z-1766-2025
Product summary
- Event
- Event 96732
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 840 units
- Official record key
device-enforcement:Z-1766-2025
Official wording
Reason: Three is the potential for the retractors to puncture through the sterile packaging.
Code information: UDI/DI 10653160287018 (each) 00653160287011 (case), Lot Numbers: 2020061990, 2020070990, 2020110490, 2020111090, 2021082590, 2021121490, 2022062890, 2022110190, 2022121990, 2023032290, 2023032390, 2023092590, 2024050790, 2024053090, 2024062490, 2024070190.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Three is the potential for the retractors to puncture through the sterile packaging.