Class 2 Device Recall EnSeal TRIO

• Date Initiated by Firm: July 09, 2010
• Date Posted: September 30, 2010
• Recall Status: Terminated on February 14, 2011
• Recall Number: Z-2635-2010
• Recall Event ID: 56292
• 510(K)Number: K070165 K070896 K072177
• Product Classification: Laparoscope, general; plastic surgery, reprocessed - Product Code NLM
• Product: Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
• Code Information: Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery Inc; 4545 Creek Rd; Cincinnati OH 45242-2803
• For Additional Information Contact: David E. Moore; 513-337-3383
• Manufacturer Reason for Recall: The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.
• FDA Determined Cause: Other
• Action: Ethicon Endo-Surgery issued an Urgent: Device Recall, Event 2193 letter dated July 19, 2010 identifying the affected device, the issue prompting the recall, and actions to be taken by consignees. Consignees were instructed: Do not use the affected product. Identify and quarantine affected product from inventory. Complete the Business Reply form and fax to Stericycle at 877-597-9580 within three days To return product, place it in a box with a copy of the Business Reply form and mail to Stericycle using the pre-printed UPS shipping label. Replacement product should be received by the customer within 60 days of return of affected product. Customers can contact Stericycle about this recall at 877-243-7314 and referencing Event 2193.
• Quantity in Commerce: 396 instruments
• Distribution: Nationwide Distribution to the following states: AZ, AL, AZ, CA, CO, CT, FL, GA, IN, KY, MA, MD, MI, MO, MS, NC, NV, NY, OH, PA, TN, TX, WA, and WV.
• 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 = NLM