Z-2157-2021 Class II Terminated
FDA device recall Z-2157-2021 was initiated by Sunrise Medical (US) LLC on July 8, 2021 and is designated Class II. Reason for recall: The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. The recall status is terminated (terminated March 28, 2025). Affected quantity: 9,865 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 4, 2021
- Initiation Date
- July 8, 2021
- Termination Date
- March 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,865 devices
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of United Kingdom, Germany, France, Canada, Italy, Netherlands, Poland, Czech Republic, Australia, Hong Kong, Japan, Qatar, Norway, United Arab Emirates, China, Saudi Arabia, Sweden, Switzerland, Spain, Indonesia, India, Singapore, Bahrain and Israel.