Recall Z-1300-2022
Changzhou Biomet Medical Devices Co., Ltd. · initiated June 2, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
Codes / lots: UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671
Reason for recall
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
FDA-determined cause: Process control
Action taken
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 CorporateQuality.PostMarket@zimmerbiomet.com.
Details
- Recall number
- Z-1300-2022
- Initiated
- June 2, 2022
- Posted by FDA
- June 28, 2022
- Terminated
- February 12, 2024
- Product code
- LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- 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.
- Recalling firm
- Changzhou Biomet Medical Devices Co., Ltd., Changzhou