Recall Z-0658-2009 ยท GCJ Laparoscope, General & Plastic Surgery
Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe (Product Code EPS04)
| Date | Jan 27, 2009 (initiated Dec 9, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 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, SINGA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912492 | EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE ETHICON, Inc., Oct 21, 1991 |