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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1300-2022 |
| Event ID | 90421 |
| Event Description | DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius. |
| Product Type | Devices |
| 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 Reason | One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates |
| Device Classification | 20220706 |
| Device Code Info | UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671 |
| Center Classification Date | 20220628 |
| Recall Initiation Date | 20220602 |
| Recalling Firm | CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. |
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