LIGACLIP Endoscopic Rotating Multiple Clip Applier… recallZ-1776-2013 · Ethicon Endo-Surgery Inc · initiated Apr 12, 2013

Why it was recalled

Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure

FDA root cause category: Under Investigation by firm

What the company is doing

Ethicon sent an Urgent : Medical Device Recall letter dated April 30, 2013 to all primary and secondary consignees via overnight UPS to allow tracking of the receipt. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately and return affected products for credit. This credit is intended to facilitate replacement purchase. For questions contact your local representative or call Ethicon Customer Support Center at 1-877-384-4266 option 6.

Recall details

Recall number

Z-1776-2013

Recall class

Class II

Status

Terminated

Initiated by the company

Apr 12, 2013

Posted by the FDA

Jul 19, 2013

Recalling firm

Ethicon Endo-Surgery Inc

Quantity

49,357

Product code

GDO

FDA submissions

K812291, K830503, K864102

Distribution

Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA and YEMEN.

Product description

LIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360 in either direction. The rotating knob is located to allow for a one-handed technique.

Other devices under the same FDA submission

5 devices cleared under K812291, K830503, K864102 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• LIGACLIP LT200

  Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE
  75 reports
• LIGACLIP LT300

  Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE
  48 reports
• LIGACLIP LT100

  Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE
  9 reports
• LIGACLIP LT400

  Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE
  8 reports
• LIGACLIP LT102

  Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 65141).

• Z-1775-2013 · Terminated
  LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instru…
• Z-1777-2013 · Terminated
  LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient us…