FDA Device recall Z-1300-2022
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the…
- FDA Device
- Class II
- terminated
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the… by Changzhou Biomet Medical Devices, citing one lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1300-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-02 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Changzhou Biomet Medical Devices |
| Distribution | US |
Product
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
Reason
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
Identifiers
| code_info | UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1300-2022%22
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