Z-1117-2015Class II

HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical...

Name: Z-1117-2015 HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical...
Creator: Intuitive Surgical, Inc.
Published: 2015-01-21
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2015-01-21 / Terminated / root cause: labeling and UDI

FDA source

Intuitive Surgical, Inc. began a recall of HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when... on 2015-01-21. FDA classified it as Class II and gives the reason as "Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1117-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-21
Posted: 2015-02-13
Terminated: 2015-06-01
Recalling firm: Intuitive Surgical, Inc.
Product: HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: A Field Safety Notice entitled, Urgent Medical Device Correction, and dated, January 21, 2015, were sent to customers. The letter identified the problem and the reason for the recall as well as the risk to health. Customers are asked to ensure that all affected personnel are informed of the notice. Additionally, customers are to discard their current Harmonic Ace IFUs. Customers are to refer to the specified manual, reference guide, and instruction card mentioned in the letter. A copy of the notice is to be retained with the da Vinci Standard, S or Si user manual. Intuitive Surgical will remove the Harmonic ACE IFU from all future shipments of the product. Representatives will be available by phone to answer questions related to the Correction.
Quantity in commerce: 12,467 - both sizes
Distribution: Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Panama, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.
Product codes and lots: PN 400274, 420274, and 420272.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1117-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1117-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-13
Z-1118-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-13

Product code NAY

K093217Class II5 Mm Harmonic Ace Instrument (Used with Da Vinci Is1200 & Is2000/is3000 System)Intuitive Surgical, Inc. / cleared 2010-01-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)