Z-1300-2022 Class II Terminated
FDA device recall Z-1300-2022 was initiated by CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. on June 2, 2022 and is designated Class II. Reason for recall: One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates The recall status is terminated (terminated February 12, 2024).
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2022
- Initiation Date
- June 2, 2022
- Termination Date
- February 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
Reason for Recall
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
Distribution Pattern
US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, IN, MA, MD, ME, MN, MT, NC, ND, NE, NH, NY, TN, VA, WA, WI.
Code Information
UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671