PlainRecalls
FDA Devices Moderate Class II Terminated

DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.

Reported: July 6, 2022 Initiated: June 2, 2022 #Z-1300-2022

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

Details

Distribution
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.
Location
Changzhou

Frequently Asked Questions

What product was recalled?
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.. Recalled by CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD..
Why was this product recalled?
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
Which agency issued this recall?
This recall was issued by the FDA Devices on July 6, 2022. Severity: Moderate. Recall number: Z-1300-2022.