DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteo
Summary
The FDA issued a Class II for DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used by CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.. Reason: One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates.
Details
Source
Device Recall
External ID
Z-1300-2022
Action Date
2022-07-06
Status
Terminated
Category
device
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.
Lot/Code Info: UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671
Reason for Recall
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-02
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. have FDA actions?
This is the only FDA action we have on record for CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1300-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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