# FDA recall Z-0095-2018

> **Arthrex, Inc.** · Class II · device recall initiated 2017-10-03.

## 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.

## Distribution

Worldwide Distribution - US including SD, NV, NC, CA, MD, AZ, CA, LA, FL, PA, TX, NY, GA, and Internationally to GERMANY, POLAND

## Key facts

- **Recall number:** Z-0095-2018
- **Recalling firm:** Arthrex, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-03
- **Report date:** 2017-11-22
- **Termination date:** 2018-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Naples, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0095-2018

## Citation

> AI Analytics. FDA recall Z-0095-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0095-2018. Source: US FDA. Licensed CC0.

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