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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 Device Recall Spider Flex Monopolar Hooksee related information
Date Initiated by FirmJune 22, 2010
Date PostedSeptember 22, 2010
Recall Status1 Terminated 3 on January 31, 2011
Recall NumberZ-2465-2010
Recall Event ID 56179
510(K)NumberK091697 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductSpider 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 NC 27703-8226
For Additional Information ContactTammy 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
ActionTransEnterix 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 Commerce46 boxes (6 units per box)
DistributionNationwide Distribution in the states of AZ, FL, GA, NC, NY, OH, OR, SC and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GCJ
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