Z-0121-2020 Class II Terminated
FDA device recall Z-0121-2020 was initiated by Centurion Medical Products Corporation on August 28, 2019 and is designated Class II. 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. The recall status is terminated (terminated July 23, 2020). Affected quantity: 204 each.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- August 28, 2019
- Termination Date
- July 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 204 each
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.
Distribution Pattern
Nationwide
Code Information
Batch/Lot: 2019061201