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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 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.

FDA Recall Z-1777-2013 · Posted 2013-07-19

Recalling FirmEthicon Endo-Surgery Inc
Recall StatusTerminated
Product CodeGDO
Date Initiated2013-04-12
Date Terminated2014-05-01
Product Quantity10,488

Reason for Recall

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

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K864102LIGACLIP 20/20* MULTIPLE CLIP APPLIERETHICON, Inc. · 1986-11-05K830503LIGACLIP TITANIUM LIGATING CLIPETHICON, Inc. · 1983-03-08K812291ETHICON MULTIPLE LIGATING CLIP APPLIERETHICON, Inc. · 1981-09-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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