DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteot
FDA device recall Z-1300-2022 · posted 2022-06-28 · Terminated
Recall details
- Recalling firm
- CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
- Reason for recall
- One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LXT
- 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.
- Date initiated
- 2022-06-02
- Date posted
- 2022-06-28
- Date terminated
- 2024-02-12
- Location
- Changzhou, China
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM (K050932) | Hand Innovations, Inc. | 2005-04-26 |