CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. recalls DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteo…

Recall date

June 2, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1300-2022

FDA classification

Class II

Brand / firm

CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.

Sold / distributed

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.

Why it was recalled

One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.