Device product
Centurion Sterile Weitlaner Retractor, Reorder: 67315
Z-1765-2025
Product summary
- Event
- Event 96732
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2100 units
- Official record key
device-enforcement:Z-1765-2025
Official wording
Reason: Three is the potential for the retractors to puncture through the sterile packaging.
Code information: UDI/DI 10653160379867 (each) 00653160379860 (case), Lot Numbers: 2020092801, 2020100601, 2021022601, 2021032301, 2021042301, 2021060101, 2021062101, 2021090790, 2022021190, 2022032390, 2022040690, 2022061690, 2022072690, 2022091490, 2023020990, 2023100590, 2023120790, 2024012990, 2024022290, 2024040590, 2024070290, 2024080190, 2024092790, 2025011490.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Three is the potential for the retractors to puncture through the sterile packaging.