Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iBalance(R) UKA Recalled by Arthrex, Inc. Due to Arthrex part number AR-501-UFLC, size 3, batch 10123297,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arthrex, Inc. directly.
Affected Products
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.
Quantity: 20 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 12 states: AZ, CA, FL, GA, LA, MD, NV, NY, NC, PA, SD, TX
About Arthrex, Inc.
Arthrex, Inc. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report