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

Recall Z-2695-2016 — ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicat

U.S. FDA — Device Enforcement · United States · 2016-06-21 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2695-2016
Date of alert: 2016-06-21
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: MicroPort Orthopedics Inc.
Product category: device
Product type: Devices

Reported risk: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.

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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