Z-1300-2022Class II

DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures...

Name: Z-1300-2022 DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures...
Creator: Changzhou Biomet Medical Devices Co., Ltd.
Published: 2022-06-02
License: https://open.fda.gov/license/

Changzhou Biomet Medical Devices Co., Ltd. / initiated 2022-06-02 / Terminated / root cause: manufacturing process

FDA source

CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. began a recall of DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius on 2022-06-02. FDA classified it as Class II and gives the reason as "One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1300-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-02
Posted: 2022-06-28
Terminated: 2024-02-12
Recalling firm: Changzhou Biomet Medical Devices Co., Ltd.
Product: DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
Product code: LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Reason for recall: One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
Root cause tag: manufacturing process
FDA 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 [email protected].
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.
Product codes and lots: UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1300-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1300-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-06	2022-06-28

Product code LXT

K050932Class IIDistal Volar Radius Anatomical Plate SystemHand Innovations, Inc. / cleared 2005-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)