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U.S. Department of Health and Human Services

Class 2 Device Recall Spider Flex Monopolar Hook

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 Class 2 Recall
Spider Flex Monopolar Hook
see related information
Date Posted September 22, 2010
Recall Status1 Terminated on January 31, 2011
Recall Number Z-2465-2010
Recall Event ID 56179
Premarket Notification
510(K) Number
K091697 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC
Code Information Model number: 9000031, The following lot numbers recalled on June 22, 2010: DSC077201001 and DSC083201001. Field action extended and the following lot numbers recalled on July 5, 2010: DSC043201001, DSC049201001, DSC079201001, DSC091201002
Recalling Firm/
Manufacturer
Transenterix, INC
3908 Patriot Dr Ste 170
Durham, North Carolina 27703-8226
For Additional Information Contact Tammy B. Carrea
919-541-9977 Ext. 140
Manufacturer Reason
for Recall
The hook end effecter from a monopolar device may become dislodged and fall into the patient when in use during laproscopic surgery. Retrieval from the patient may involve extended anesthesia time.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action TransEnterix issued a "Field Action" letter dated June 22, 2010 to consignees, identifying the affected product and actions to be taken by the customer. Customers were instructed to return the product to TransEnterix, Inc. using the address label and return information provided. The firm will replace the product at no charge. TransEnterix Customer Care can be contacted at 1-888-879-4111.
Quantity in Commerce 46 boxes (6 units per box)
Distribution Nationwide Distribution in the states of AZ, FL, GA, NC, NY, OH, OR, SC and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = TRANSENTERIX, INC.
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