DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
FDA Recall Z-1300-2022 · Posted 2022-06-28
Recalling FirmCHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
Recall StatusTerminated
Product CodeLXT
Date Initiated2022-06-02
Date Terminated2024-02-12
Reason for Recall
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
Firm Action
On June 2, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to return all affected product.
If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.