FDA recall Z-1300-2022

CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. · Class II · device

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 for recall

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.

Key facts

Status
Terminated
Initiation date
2022-06-02
Report date
2022-07-06
Termination date
2024-02-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Changzhou, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1300-2022