—#171793

Product

Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A 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.

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K940967, K983536
Affected lot / code info: All Lots within EXPIRATION Date Range: February 2023 March 2024

Why it was recalled

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Blue Ash, Ohio 45242-2803

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.