Z-2453-2021 Class II Ongoing
FDA device recall Z-2453-2021 was initiated by Accora Inc on June 21, 2021 and is designated Class II. Reason for recall: The firm has identified a potential for the backrest to become detached from the chair. The recall status is ongoing. Affected quantity: 122 (US); 270 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- June 21, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 122 (US); 270 (OUS)
Product Description
Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20. Model Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.
Reason for Recall
The firm has identified a potential for the backrest to become detached from the chair.
Distribution Pattern
Worldwide distribution - US Nationwide in the states of AL, FL, IL, MN, MS, NH, NJ, NY, NC, OH, PA, SC and the countries of Ireland, UK, and Australia.
Code Information
Serial Numbers (Domestically distributed) 10001-SC3-20 to 10115-SC3-20 10146-SC3-20 to 10235-SC3-20