Recall Z-0095-2018— Arthrex, Inc.

Name: FDA recall Z-0095-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-03

Class II · Terminated

Class II FDA medical device recall by Arthrex, Inc., initiated 2017-10-03, terminated 2018-12-04. It names one FDA 510(k) clearance: K060670. 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.. Reason: 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..

Recalling firm: Arthrex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-03
Terminated: 2018-12-04
Firm location: Naples, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K060670 — ACCIN UNI-KNEE SYSTEMAccin Corporation·cleared 2006-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.