FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1300-2022
- 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.
- Status
- Terminated
- Initiated
- 2022-06-02
- Posted
- 2022-06-28
- Terminated
- 2024-02-12
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671
- 510(k) numbers
- ["K050932"]
- PMA numbers
- not on file
- Product code
- LXT
- Firm FEI
- 3007923096
- Firm city
- Changzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28