FDA Medical Device Recalls (openFDA)
Transenterix, INC: Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC
- Recall number
- Z-2465-2010
- Recalling firm
- Transenterix, INC
- Product
- Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix, Inc., Durham, NC
- Status
- Terminated
- Initiated
- 2010-06-22
- Posted
- 2010-09-22
- Terminated
- 2011-01-31
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K091697"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3007593944
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28