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Class 2 Device Recall Spider Flex Monopolar Hook |
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Date Initiated by Firm |
June 22, 2010 |
Date Posted |
September 22, 2010 |
Recall Status1 |
Terminated 3 on January 31, 2011 |
Recall Number |
Z-2465-2010 |
Recall Event ID |
56179 |
510(K)Number |
K091697
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Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
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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 NC 27703-8226
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For Additional Information Contact |
Tammy B. Carrea 919-541-9977 Ext. 140
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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.
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FDA Determined Cause 2 |
Other |
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
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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.
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510(K) Database |
510(K)s with Product Code = GCJ and Original Applicant = TRANSENTERIX, INC.
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