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U.S. Department of Health and Human Services

Class 2 Device Recall iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL

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  Class 2 Device Recall iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL see related information
Date Initiated by Firm October 03, 2017
Create Date November 16, 2017
Recall Status1 Terminated 3 on December 04, 2018
Recall Number Z-0095-2018
Recall Event ID 78297
510(K)Number K060670  
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
Product 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.
Code Information batch 10123297
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 20 units
Distribution Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
Total Product Life Cycle TPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSX and Original Applicant = ACCIN CORPORATION
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