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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Spider Flex Monopolar Hook		see related information
Date Posted September 22, 2010
Recall Number Z-2465-2010
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
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.
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.
 
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