Z-1909-2011

SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument...

Name: Z-1909-2011 SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument...
Creator: Transenterix, Inc
Published: 2011-02-25
License: https://open.fda.gov/license/

Asensus Surgical, Inc. / initiated 2011-02-25 / Terminated

FDA source

Transenterix, Inc began a recall of SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The... on 2011-02-25. The reason FDA records is "Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1909-2011
Status: Terminated
Initiated: 2011-02-25
Posted: 2011-04-08
Terminated: 2011-11-07
Recalling firm: Asensus Surgical, 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.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
FDA 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 in commerce: 305 units
Distribution: Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA
Product codes and lots: Model number: 9000020, Lot numbers: TRX044201001, TRX085201001, TRX086201001, TRX086201002, TRX099201001, TRX099201002, TRX112201002, TRX169201001, TRX169201002 and TRX169201001R.

Product code GCJ

K090902Class IISpider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Transenterix, Inc. / cleared 2009-07-22

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)