Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC
FDA device recall Z-2465-2010 · posted 2010-09-22 · Terminated
Recall details
- Recalling firm
- Transenterix, INC
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 46 boxes (6 units per box)
- Distribution
- Nationwide Distribution in the states of AZ, FL, GA, NC, NY, OH, OR, SC and TX.
- Date initiated
- 2010-06-22
- Date posted
- 2010-09-22
- Date terminated
- 2011-01-31
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 (K091697) | Transenterix, Inc. | 2009-09-28 |