U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Arthrex part number ar-501-uflc, size 3, batch 10123297, has the incorrect part number ar-501 ¿ufra, size 1 printed on the patient label inside the box.
조치
Arthrex sent an Urgent Medical Device Voluntary Recall letter on October 3, 2017. The letter requested the following:
"Immediately discontinue use of these devices. In order to receive
credit for the returned devices, please follow the steps below:
1) Review this notification and ensure affected personnel are aware of the contents.
2) Immediately identify and return all the indicated product/batch numbers you have in inventory. Call Arthrex Field Logistics Service at 1-866¿612-7899 for a returned goods authorization (RGA) and product return instructions. Email: FLS@Arthrex.com."
Customers with questions were instructed to call Product Surveillance at 866-267-9138 or by email to commplaints@arthrex.com.
Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
제품 설명
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL || Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.