Recall Z-1300-2022— CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
Class II · Terminated
Class II FDA medical device recall by CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD., initiated 2022-06-02, terminated 2024-02-12. It names one FDA 510(k) clearance: K050932. 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.
- Recalling firm
- CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-06-02
- Terminated
- 2024-02-12
- Firm location
- Changzhou, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
Data sourced from openFDA. This site is unofficial and independent of the FDA.