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U.S. Department of Health and Human Services

Class 1 Device Recall Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A

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  Class 1 Device Recall Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A see related information
Date Initiated by Firm April 11, 2019
Create Date May 15, 2019
Recall Status1 Completed
Recall Number Z-1267-2019
Recall Event ID 82539
510(K)Number K983536  
Product Classification Staple, implantable - Product Code GDW
Product Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A

The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.
Code Information All Lots within EXPIRATION Date Range: December 2022 March 2024
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information Contact Krystina Monaco
513-337-8256
Manufacturer Reason
for Recall		 The staplers may have an insufficient firing stroke to break the washer and completely form staples.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, ETHICON, sent an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" letters to US customers beginning 4/11/19. The letters described the product, problem and actions to be taken. The customers were instructed to the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this voluntary recall (removal). 3. It is not necessary to contact your end customers regarding this action. Ethicon will directly communicate with customers about the above listed product subject to this recall (removal). 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email it to Stericycle at 866-873-0312 or ethicon5011@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall (removal). 5. Keep this notice visibly posted for awareness until all product subject to this recall (removal) has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. 6. Distributors are required to return unused impacted Intraluminal Stapler (ILS) subject to this recall (removal) that are in their inventory immediately. Only Intraluminal Stapler (ILS) subject to this recall (removal) returned by June 30, 2019 will be eligible for credit reimbursement. Any product subject to this recall (removal) returned after the date specified will not be eligible for credit reimbursement. 7. To return product subject to this recall (removal), photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Stericycle at 1-888-671-88
Quantity in Commerce 434,614 total
Distribution Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Nepal. Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, UAE, Uruguay, Vietnam, and Yemen.
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.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = ETHICON ENDO-SURGERY, INC.
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