—#75727

Product

Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product Code EPS09)

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K912492
Affected lot / code info: Product code EPS09 - Lot # E4KC2H, Exp. Date 2013-01; Lot # E4KJ1H, Exp. Date 2013-02; Lot # E4KR73, Exp. Date 2013-03; Lot # E4KW8R, Exp. Date 2013-03; Lot # E4L465, Exp. Date 2013-04; Lot # E4LA5T, Exp. Date 2013-05; Lot # E4LD9H, Exp. Date 2013-05; Lot # E4LF6M, Exp. Date 2013-05; Lot # E4LK7U, Exp. Date 2013-06; Lot # E4LU3N, Exp. Date 2013-07; Lot # E4M33D, Exp. Date 2013-08; Lot # E4M69J, Exp. Date 2013-09; and Lot # E4M83N, Exp. Date 2013-09.

Why it was recalled

Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens

Root cause (FDA determination)

Process design

Action the firm took

On 12/9/2008 Ethicon Endo-Surgery sent recall notification letters to their customers instructing them to stop using the product, examine all inventory to determine if they have the affected product on hand and remove the affected products from inventory. They requested that each customer complete the Business Reply Form and fax it back to Stericycle and also return any affected product to Stericycle.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA, PUERTO RICO, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, DOMINICAN REPUBLIC, EGYPT, ENGLAND, EQUADOR, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, PAKISTAN, PANAMA, POLAND, REPUBLIC OF YEMEN, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, URUGUAY, and VENEZUELA.

Timeline

Recall initiated: 2008-12-09
Posted by FDA: 2009-01-27
Terminated: 2010-10-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.