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Intuitive Surgical, Inc. recalls daVinci Harmonic ACE Curved Shears
Recalled February 27, 2019 · FDA recall Z-0841-2019 · Intuitive Surgical
Hazard
During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility. · FDA Class II
Units
43755 inserts
Sold at
US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom
Description
During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.
Product
daVinci Harmonic ACE Curved Shears
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →