Z-0660-2007

8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive...

Name: Z-0660-2007 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive...
Creator: Intuitive Surgical, Inc.
Published: 2005-03-24
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2005-03-24 / Terminated

FDA source

Intuitive Surgical, Inc. began a recall of 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA on 2005-03-24. The reason FDA records is "The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0660-2007
Status: Terminated
Initiated: 2005-03-24
Posted: 2007-03-28
Terminated: 2007-11-28
Recalling firm: Intuitive Surgical, Inc.
Product: 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.
FDA root cause: Other
Action: The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.
Quantity in commerce: 8
Distribution: Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany.
Product codes and lots: The 8mm EndoWrist Bipolar Maryland Instrument is manufactured in lots, and traceability is maintained for each lot. A two digit unique identifier is added to the lot number label on the instruments, and programming records are traceable to these identifiers. The following 8 instruments from lot # 0503051 are affected: 0503051 66, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73.

Product code NAY

K012833Class IIIntuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc. / cleared 2001-11-16

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)