Z-0841-2019 Class II Ongoing
FDA device recall Z-0841-2019 was initiated by Intuitive Surgical, Inc. on January 16, 2019 and is designated Class II. Reason for recall: 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 s… The recall status is ongoing. Affected quantity: 43755 inserts.
Recall Details
- Product Type
- Devices
- Report Date
- February 27, 2019
- Initiation Date
- January 16, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43755 inserts
Product Description
daVinci Harmonic ACE Curved Shears
Reason for Recall
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.
Distribution Pattern
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
Code Information
All Lots