Changzhou, China
CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. recalls
1 recall recorded since 2018, most recently on 2 June 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 June 2022
- Terminated
- 12 February 2024
- Reason
- One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1300-2022
- DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.