Z-0095-2018Class II

iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY...

Name: Z-0095-2018 iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY...
Creator: Arthrex, Inc.
Published: 2017-10-03
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2017-10-03 / Terminated / root cause: manufacturing process

FDA source

Arthrex, Inc. began a recall of 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... on 2017-10-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0095-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-03
Posted: 2017-11-16
Terminated: 2018-12-04
Recalling firm: Arthrex GmbH
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.
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 20 units
Distribution: Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
Product codes and lots: batch 10123297

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0095-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0095-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-22	2017-11-16

Product code HSX

K060670Class IIAccin Uni-Knee SystemAccin Corporation / cleared 2006-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)