Class 2 Device Recall Centurion

• Date Initiated by Firm: August 28, 2019
• Create Date: October 10, 2019
• Recall Status: Terminated on July 23, 2020
• Recall Number: Z-0120-2020
• Recall Event ID: 83774
• 510(K)Number: K890897
• Product Classification: Clamp, circumcision - Product Code HFX
• 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
• Code Information: Batch/Lot: 2019061801
• Recalling Firm/ Manufacturer: Centurion Medical Products Corporation; 100 Centurion Way; Williamston MI 48895-9086
• For Additional Information Contact: Lisa A. Carpenter; 517-546-5400 Ext. 1156
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: Centurion Medical Products issued Notification via Certified Mail, Return Receipt on 8/28/19 to customers who received affected product. Letter states reason for recall, helath risk and action to take: identify inventory within your possession and cease use immediately. Complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of your response Centurion Representative will contact you regarding retrieval of the product from your facility, if required. Forward this recall information to any facilities to whom this product may have been further distributed, instructing them to cease use immediately. Questions: Kara A. Kowalczy Director of Quality Assurance(517) 546-5400 Ext.1122. Centurion mailed four (4) additional customer letters on 9/27 /2019 via Certified Mail, Return Receipt.
• Quantity in Commerce: 1530 each
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HFX