Recall Z-0121-2020— Centurion Medical Products Corporation

Name: FDA recall Z-0121-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-28

Class II · Terminated

Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-08-28, terminated 2020-07-23. It names one FDA 510(k) clearance: K890897. 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: 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..

Recalling firm: Centurion Medical Products Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-08-28
Terminated: 2020-07-23
Firm location: Williamston, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K890897 — CENTURION CIRCLAMPTri-State Hospital Supply Corp.·cleared 1989-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.