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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 Staplerssee related information
Date Initiated by FirmOctober 23, 2017
Create DateFebruary 21, 2018
Recall Status1 Terminated 3 on July 18, 2019
Recall NumberZ-0672-2018
Recall Event ID 79246
510(K)NumberK983536 
Product Classification Staple, implantable - Product Code GDW
ProductDisposable 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
ActionEthicon 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 Commerce148.913
DistributionChina
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GDW
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