Reported Jul 6, 2022 · Terminated
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and…
Changzhou Biomet Medical Devices Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. · No. 235 Longhutangjieban Chuangxindadao · Changzhou · N/A
Is this the product you have?
- DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
- Lot codes and dates
- UDI(01)00887868070853 (11)210429(10)J7014671 Lot J7014671
Where it was sold
Why it was recalled
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
This product could cause temporary or reversible health problems — stop using it.
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