Class 2 Device Recall ENDOPATH Probe Plus II

• Date Initiated by Firm: December 09, 2008
• Date Posted: January 27, 2009
• Recall Status: Terminated on October 20, 2010
• Recall Number: Z-0656-2009
• Recall Event ID: 50510
• 510(K)Number: K912492
• Product Classification: Electrosurgery Probe - Product Code GCJ
• Product: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product Code EPS02)
• Code Information: Product Code EPS02 - Lot # E4K181, Exp. Date 2012-12; Lot # E4K58C, Exp. Date 2012-12; Lot # E4KC5X, Exp. Date 2013-01; Lot # E4KD1P, Exp. Date 2013-01; Lot # E4KF2N, Exp. Date 2013-01; Lot # E4KG70, Exp. Date 2013-01; Lot # E4KK22, Exp. Date 2013-02; Lot # E4KP2F, Exp. Date 2013-02; Lot # E4KV17, Exp. Date 2013-03; Lot # E4KY1A, Exp. Date 2013-03; Lot # E4KY70, Exp. Date 2013-03; Lot # E4L03H, Exp. Date 2013-04; Lot # E4L519, Exp. Date 2013-04; Lot # E4L73Z, Exp. Date 2013-05; Lot # E4L916, Exp. Date 2013-05; Lot # E4LC3K, Exp. Date 2013-05; Lot # E4LD8L, Exp. Date 2013-05; Lot # E4LF60, Exp. Date 2013-05; Lot # E4LG4D, Exp. Date 2013-06; Lot # E4LL7P, Exp. Date 2013-06; Lot # E4LT6E, Exp. Date 2013-07; Lot # E4LX4H, Exp. Date 2013-07; Lot # E4M045, Exp. Date 2013-08; Lot # E4M12L, Exp. Date 2013-08; Lot # E4M27N, Exp. Date 2013-08; Lot # E4M466, Exp. Date 2013-08; Lot # E4M535, Exp. Date 2013-08; Lot # E4M54F, Exp. Date 2013-08; Lot # E4M69H, Exp. Date 2013-09; Lot # E4M838, Exp. Date 2013-09; Lot # E4MA4M, Exp. Date 2013-09; and Lot # E4MC3A, Exp. Date 2013-09
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery Inc; 4545 Creek Rd; Cincinnati OH 45242-2803
• For Additional Information Contact: Dave Moore; 513-337-3383
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Process design
• Action: 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.
• Quantity in Commerce: 32 lots, 18,528 pieces
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GCJ