Z-1890-2020 Class II Ongoing
FDA device recall Z-1890-2020 was initiated by Intuitive Surgical, Inc. on July 1, 2019 and is designated Class II. Reason for recall: The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple lin… The recall status is ongoing. Affected quantity: 22,752 reloads.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- July 1, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,752 reloads
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide including in the states of AL, AK, AZ, AR, CA, CO, CT, DE, D.C., FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI and the countries of Australia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Switzerland, United Kingdom.