Device product
36MM COCR MODULAR HD -6MM
Z-1008-2018
Product summary
- Event
- Event 79254
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23
- Official record key
device-enforcement:Z-1008-2018
Official wording
Reason: One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
Code information: 11-363660 UDI Number: (01) 00880304210509 (17) 270507 (10) 236840 Product Number: 11-363660 Lot Number: 236840
Distribution pattern: Outside USA
Derived failure modes
-
Unknown
One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.