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.
FDA Recall Z-0095-2018 · Posted None
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Recalling FirmArthrex, Inc.
Recall StatusTerminated
Product CodeHSX
Date Initiated2017-10-03
Date Terminated2018-12-04
Product Quantity20 units
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.
Firm 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 1-866612-7899 for a returned goods authorization (RGA) and product return instructions. Email: [email protected]."
Customers with questions were instructed to call Product Surveillance at 866-267-9138 or by email to [email protected].
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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