Recall Z-1300-2022 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
| Date | Jun 28, 2022 (initiated Jun 2, 2022) |
| Status | Terminated |
| Reason | One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates |
| Root cause | Process control |
| 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 CorporateQuality.PostMarket@zimmerbiomet.com. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM Hand Innovations, Inc., Apr 26, 2005 |