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

Recall Z-1128-2018 — U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to r

U.S. FDA — Device Enforcement · Taiwan · 2017-11-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1128-2018
Date of alert: 2017-11-24
Country / jurisdiction: Taiwan
Risk level: Class II
Risk type: recall
Brand: United Orthopedic Corporation
Product category: device
Product type: Devices

Reported risk: UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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