The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long

FDA device recall Z-1627-2012 · posted 2012-05-18 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. If the component exhibits this issue, the device does not open either with the anvil release button or with the manual firing release lever.

Action taken

Ethicon Endo-Surgery sent an Urgent Device Recall letter dated March 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have the affected product and to remove the affected product. Fill out the Business Reply Form and fax it to 1-513-337-4138 within 3 business days, even if they do not have the affected product in their inventory. Ethicon will automatically replace any affected product returned by June 29, 2012. Customers were asked to share this information with appropriate staff. If customers should need clinical or product support call 1-800-873-3636, option 6, or contact their local sales representative. For questions regarding this recall call 513-337-7000.

Root cause

Vendor change control

Status

Terminated

Product code

GDW

Quantity affected

3120

Distribution

Worldwide Distribution - USA including AL, AR, CA, CO, FL, IA, IL, KS, LA, MD, MO, MS, NC, NM, NY, OH, SC, TX & VA; and the countries of Argentina, Ecuador, Mexico, Australia, Egypt, Singapore, Belgiu

Date initiated

2012-03-02

Date posted

2012-05-18

Date terminated

2013-03-22

Location

Cincinnati, OH

Related 510(k) clearances