CLASS II Device recall · Reported 22 Nov 2017 · FDA Enforcement Report
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right Lateral recalled
Arthrex is recalling iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right Lateral, distributed nationwide in the US. The recall was initiated on 3 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0095-2018
- FDA event ID
- 78297
- Recalling firm
- Arthrex, Naples, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Oct 2017
- FDA classified
- 16 Nov 2017
- Reported
- 22 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 3 Oct 2017 | Recall initiated by company | |
| 16 Nov 2017 | Classified by FDA | +44 days |
| 22 Nov 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
Nationwide ArizonaCaliforniaFloridaGeorgiaLouisianaMarylandNorth CarolinaNevadaNew YorkPennsylvaniaSouth DakotaTexas
Questions about this recall
Is iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right Lateral recalled?
Yes. Arthrex recalled iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right Lateral on 3 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0095-2018.
Why was it 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.
Which lots are affected?
batch 10123297
Where was it sold?
Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Arthrex
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Small Joint OATS Set recalled by Arthrex | Arthrex | Sterility | 20 states |
| Device | CLASS II | K-Wire, 1.35 mm x 170 mm recalled by Arthrex | Arthrex | Other | Nationwide |
| Device | CLASS II | Suture Anchor, BioComposite SwiveLock C, Closed Eyelet recalled | Arthrex | Sterility | Nationwide |
| Device | CLASS II | Tibial Opening Wedge Osteotomy Plate, Titanium recalled by Arthrex | Arthrex | Other | Nationwide |
| Device | CLASS II | Drill Bit, Cannulated recalled by Arthrex | Arthrex | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |