FDA Medical Device Recalls (openFDA)
Transenterix, Inc: SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.
- Recall number
- Z-1909-2011
- Recalling firm
- Transenterix, Inc
- Product
- SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.
- Status
- Terminated
- Initiated
- 2011-02-25
- Posted
- 2011-04-08
- Terminated
- 2011-11-07
- Reason
- Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
- Root cause
- Other
- Action
- TransEnterix sent an Urgent Device Recall letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the lot numbers affected, complete the attached inventory reconciliation form and return the form, along with any affected product to TransEnterix using the enclosed shipping label. Customers were asked to return the inventory form even if they had none of the lot numbers affected in their inventory. Their sales representative and customer service will work with them to replace the product in full at not cost to them. For questions regarding this recall contact TransEnterix Customer Care at 1-888-879-4111.
- Quantity
- 305 units
- Distribution
- Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA
- Lot, serial or model codes
- Model number: 9000020, Lot numbers: TRX044201001, TRX085201001, TRX086201001, TRX086201002, TRX099201001, TRX099201002, TRX112201002, TRX169201001, TRX169201002 and TRX169201001R.
- 510(k) numbers
- ["K090902"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3007593944
- Firm city
- Morrisville
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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