Device product
Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR
Z-0120-2020
Product summary
- Event
- Event 83774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1530 each
- Official record key
device-enforcement:Z-0120-2020
Official wording
Reason: A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
Code information: Batch/Lot: 2019061801
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.