Arthrex iBalance UKA Size 3: Incorrect Part Number Risk
Arthrex recalls iBalance UKA Size 3 implants with incorrect part number AR-501-UFLC on patient labels. This may lead to improper surgical use. Affected units have batch 10123297 and are prescription-only.
Lower-risk 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.
Contact the company
What happened, in plain English
Arthrex is recalling specific knee implants (iBalance UKA Size 3) that have the wrong part number printed on their patient labels. This could cause improper surgical use if the wrong implant is installed. The recall affects prescription-only units sold with batch number 10123297. Read more at govinfonow.com/recall/72914-arthrex-ibalance-uka-size-3-incorrect-part-number-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72914-arthrex-ibalance-uka-size-3-incorrect-part-number-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0095-2018
Cite this page
“Arthrex iBalance UKA Size 3: Incorrect Part Number Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72914-arthrex-ibalance-uka-size-3-incorrect-part-number-risk. Based on FDA recall #Z-0095-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0095-2018%22&limit=1).
Why it’s dangerous
The patient label inside the box shows the incorrect part number AR-501-UFLC instead of AR-501-UFLC. This mismatch could lead to using the wrong implant during surgery, potentially causing improper joint repair.
Who’s affected
Prescription-only knee implants for specific surgical procedures. Patients who received this exact model with batch 10123297 are most at risk.
How to tell if you have this one
Check for the part number AR-501-UFLC on the patient label inside the box. The affected units have batch number 10123297 and are prescription-only for knee surgery.
- Brand
Arthrex- Category
Medical device
What to do — step by step
Check Patient Label
Look for the part number AR-501-UFLC printed on the patient label inside the box. If it shows AR-501-UFLC instead of AR-501-UFLC, this unit is affected.
Where it went and when
Where it was distributed
Distributed in 12 states, and outside the U.S.
FDA distribution: “Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Georgia, Louisiana, Maryland, Nevada, New York, North Carolina, Pennsylvania, South Dakota, Texas.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
The recall is for a labeling error that could lead to using the wrong implant during surgery, but the hazard level is low risk as the remedy does not require immediate stop-use.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0095-2018 (October 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0095-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.