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U.S. Department of Health and Human Services

Class 2 Device Recall EnSeal TRIO

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  Class 2 Device Recall EnSeal TRIO see related information
Date Initiated by Firm July 09, 2010
Date Posted September 30, 2010
Recall Status1 Terminated 3 on February 14, 2011
Recall Number Z-2635-2010
Recall Event ID 56292
510(K)Number K072177  K070896  K070165  
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 2		 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 and Original Applicant = SURGRX, INC.
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