iBalance — Class II medical device recall Z-0095-2018

Terminated recall by Arthrex, Inc., reported 2017-11-22, distributed in AZ, CA, FL, GA, LA, MD, NC, NV…. Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UFRA, size 1 pr

Recall number	`Z-0095-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Arthrex, Inc., Naples, FL, United States
Recall initiated	2017-10-03
Classified	2017-11-16
Reported by FDA	2017-11-22
Terminated	2018-12-04
Distributed	AZ, CA, FL, GA, LA, MD, NC, NV, NY, PA, SD, TX
Countries outside the US	DE, PL
Quantity	20 units
Reason classes	labeling
Lot numbers	`10123297`
Model numbers	`501-UFLC`

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0095-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.