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

Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone — recall Z-1195-2016

U.S. FDA — Device Enforcement · United States · 2015-12-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1195-2016
Date of alert: 2015-12-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Arthrex, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00888867106703

Reported risk: Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

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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