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U.S. Department of Health and Human Services

Class 2 Device Recall Proximate Curved and Straight Intraluminal Staplers

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  Class 2 Device Recall Proximate Curved and Straight Intraluminal Staplers see related information
Date Initiated by Firm October 23, 2017
Create Date February 21, 2018
Recall Status1 Open3, Classified
Recall Number Z-0672-2018
Recall Event ID 79246
510(K)Number K983536  
Product Classification Staple, implantable - Product Code GDW
Product Disposable Curved Circular Staplers

Product Usage:
Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Code Information CCS25, CCS29
Recalling Firm/
Manufacturer
Ethicon Endo-Surgery Inc
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information Contact
513-337-7000
Manufacturer Reason
for Recall
There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
FDA Determined
Cause 2
Under Investigation by firm
Action Ethicon Johnson & Johnson Affiliates in Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. The letter identified the affected product, problems and actions to be taken.
Quantity in Commerce 148.913
Distribution China
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = ETHICON ENDO-SURGERY, INC.
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