Reported Feb 27, 2019 · Ongoing
daVinci Harmonic ACE Curved Shears
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- daVinci Harmonic ACE Curved Shears
- Lot codes and dates
- All Lots
- Amount recalled
- 43755 inserts
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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