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

Recall Z-0689-2017 — Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028 Conserve: 38013800, 38013804, 38013835, 38014000, 38014004, 38014035, 38014200, 38014204, 38014235, 38014400, 38014404, 38014435, 38014600

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

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0689-2017
Date of alert: 2016-06-21
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: MicroPort Orthopedics Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 26000017

Reported risk: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

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

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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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