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.
This recall has been terminated (originally issued October 3, 2017).
- Company
- Arthrex, Inc.
- Recall Initiated
- October 3, 2017
- Terminated
- December 4, 2018
- Recall Number
- Z-0095-2018
- Quantity
- 20 units
- Firm Location
- Naples, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
Lot / Code Info
batch 10123297
Root Cause
Process control
Action Taken
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 1-866612-7899 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.