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Recall Observatory FDA recall evidence

Device product

Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR

Z-0121-2020

August 28, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 83774
Status
Terminated
Classification
Class II
Quantity
204 each
Official record key
device-enforcement:Z-0121-2020

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: 2019061201

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.