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Class 2 Device Recall PRO 2 Device |
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Date Initiated by Firm |
November 30, 2016 |
Create Date |
February 08, 2017 |
Recall Status1 |
Terminated 3 on February 15, 2018 |
Recall Number |
Z-1148-2017 |
Recall Event ID |
76017 |
510(K)Number |
K160454
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Product Classification |
Clip, implantable - Product Code FZP
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Product |
AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged into one (1) corrugate shipper box. |
Code Information |
Model Numbers: PRO235, PRO240, PRO245, PRO250 Lot Numbers: 67102 to 68418 |
Recalling Firm/ Manufacturer |
AtriCure, Inc. 7555 Innovation Way Mason OH 45040-9695
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For Additional Information Contact |
Mr. Anupam K. Bedi 866-349-2342
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Manufacturer Reason for Recall |
A complaint of the PRO2 jaw breaking prior to surgery being performed.
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FDA Determined Cause 2 |
Component design/selection |
Action |
Recall notification letters were mailed to all Atricure customers. Email notification letters were forwarded to all Atricure field-based personnel, who may also conduct in-person meetings. Telephone calls will be made as needed and effectiveness checks will be conducted. |
Quantity in Commerce |
464 units |
Distribution |
Devices were distributed in the following states: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, & WI.
Devices were distributed in the following countries: Austria, Germany, Netherlands, Poland, Sweden, Switzerland and United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FZP and Original Applicant = ATRICURE, INC.
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