—#176699

Product

ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K140560
Affected lot / code info: Lot: T93Z1G, T93Y4M, T94045, T94117, T93X17, T94087, T93Z2X, T9405L, T94253, T93X95, T93Z75, T93Z2W, T9413Z

Why it was recalled

The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Urgent Medical Device Recall (Removal) letters were sent to customers beginning 10/3/19. The letters instruct customers to do the following: ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this voluntary recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email it to Stericycle at 1-866-300-3432 or ethicon7148@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 6. Customers are required to return unused impacted ECHELON FLEX ENDOPATH 60mm Staplers subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by December 31, 2019. Any nonaffected product and any product returned after the date specified will not be replaced. 7. To return product subject to this recall, 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 1-866-918-8756. Your account n

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.

Timeline

Recall initiated: 2019-10-03
Posted by FDA: 2019-10-29
Terminated: 2021-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176699. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.