FDAClass IIJuly 6, 2022

DVR Anatomic recall

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

Why was DVR Anatomic recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671

Product
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal…
Recalling firm
CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
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.
Recall date
July 6, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls