CLASS II Device recall · Reported 25 Feb 2015 · FDA Enforcement Report
Harmonic ACE Curved Shears Instructions for Use, IS1200 recalled
Intuitive Surgical is recalling Harmonic ACE Curved Shears Instructions for Use, IS1200, distributed in Puerto Rico. The recall was initiated on 21 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1117-2015
- FDA event ID
- 70275
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2015
- FDA classified
- 13 Feb 2015
- Reported
- 25 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 21 Jan 2015 | Recall initiated by company | |
| 13 Feb 2015 | Classified by FDA | +23 days |
| 25 Feb 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Is Harmonic ACE Curved Shears Instructions for Use, IS1200 recalled?
Yes. Intuitive Surgical recalled Harmonic ACE Curved Shears Instructions for Use, IS1200 on 21 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1117-2015.
Why was it recalled?
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
Which lots are affected?
PN 400274, 420274, and 420272.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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