FDA recall Z-0121-2020

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

Reason for recall

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-08-28

Report date

2019-10-16

Termination date

2020-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Williamston, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0121-2020