Z-2465-2010

Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC

Name: Z-2465-2010 Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC
Creator: Transenterix, INC
Published: 2010-06-22
License: https://open.fda.gov/license/

Asensus Surgical, Inc. / initiated 2010-06-22 / Terminated

FDA source

Transenterix, INC began a recall of Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC on 2010-06-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2465-2010
Status: Terminated
Initiated: 2010-06-22
Posted: 2010-09-22
Terminated: 2011-01-31
Recalling firm: Asensus Surgical, Inc.
Product: Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC
Product code: GCJ Laparoscope, General & Plastic Surgery
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 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 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.
Product codes and lots: 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

Product code GCJ

K091697Class IISpider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015Transenterix, Inc. / cleared 2009-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)