Home / Recalls / Arthrex, Inc. / Z-0095-2018

Z-0095-2018 Class II Terminated

Recalled by Arthrex, Inc. — Naples, FL

Recall Details

Product Type
Devices
Report Date
November 22, 2017
Initiation Date
October 3, 2017
Termination Date
December 4, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 units

Product Description

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.

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 Pattern

Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND

Code Information

batch 10123297

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