Recall Z-2465-2010 ยท GCJ Laparoscope, General & Plastic Surgery
Transenterix, INC
Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC
| Date | Sep 22, 2010 (initiated Jun 22, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 46 boxes (6 units per box) |
| Distribution | Nationwide Distribution in the states of AZ, FL, GA, NC, NY, OH, OR, SC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091697 | SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 Transenterix, Inc., Sep 28, 2009 |