Z-1300-2022 Class II Terminated

Recalled by CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. — Changzhou

Recall Details

Product Type
Devices
Report Date
July 6, 2022
Initiation Date
June 2, 2022
Termination Date
February 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

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

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.

Code Information

UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671