Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 osteoarthriti — recall Z-0095-2018

U.S. FDA — Device Enforcement · United States · 2017-10-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0095-2018
Date of alert: 2017-10-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Arthrex, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10123297

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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