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CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. Recall 90421

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

CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. Recall 90421 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1300-2022
Event ID90421
Event DescriptionDVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
Product TypeDevices
DistributionUS 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 ReasonOne lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
Device Classification20220706
Device Code InfoUDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671
Center Classification Date20220628
Recall Initiation Date20220602
Recalling FirmCHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
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