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Class 2 Device Recall DVR Anatomic |
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Date Initiated by Firm |
June 02, 2022 |
Date Posted |
June 28, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1300-2022 |
Recall Event ID |
90421 |
510(K)Number |
K050932
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Product Classification |
Appliance, fixation, nail/blade/plate combination, multiple component, metal composite - Product Code LXT
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Product |
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius. |
Code Information |
UDI: (01)00887868070853
(11)210429(10)J7014671
Lot J7014671 |
Recalling Firm/ Manufacturer |
CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. No. 235 Longhutangjieban Chuangxindadao Xinbei Changzhou China
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For Additional Information Contact |
411 Technical Services 574-3713071
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Manufacturer Reason for Recall |
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
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FDA Determined Cause 2 |
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.
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = LXT and Original Applicant = HAND INNOVATIONS, INC.
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