Device product
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
Z-1300-2022
Product summary
- Event
- Event 90421
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1300-2022
Official wording
Reason: One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
Code information: UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671
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.
Derived failure modes
-
Unknown
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates