Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ENDOPATH Probe Plus II

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ENDOPATH Probe Plus II see related information
Date Initiated by Firm December 09, 2008
Date Posted January 27, 2009
Recall Status1 Terminated 3 on October 20, 2010
Recall Number Z-0658-2009
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 Curved Dissector Probe (Product Code EPS04)
Code Information Product Code EPS04 - Lot # E4KC2J, Exp. Date 2013-01; Lot # E4KG8M, Exp. Date 2013-01; Lot # E4KP8H, Exp. Date 2013-02; Lot # E4KV0T, Exp. Date 2013-03; Lot # E4L030, Exp. Date 2013-04; Lot # E4L892, Exp. Date 2013-05; Lot # E4LD0R, Exp. Date 2013-05; Lot # E4LK7V, Exp. Date 2013-06; Lot # E4LX1D, Exp. Date 2013-07; Lot # E4M072, Exp. Date 2013-08; Lot # E4M28F, Exp. Date 2013-08; Lot # E4M91D, Exp. Date 2013-09; and Lot # E4MA2P, 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 2		 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 13 lots, 2,304 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 and Original Applicant = ETHICON, INC.
-
-