The Recall Desk

FDA (Devices) recall action 75063

MicroPort Orthopedics Inc. recalled 7 products on 2016-12-07

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2016-12-07
Critical
0
Units
256,563

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–7 of 7

  • ModerateFDA (Devices)··2016-12-07

    MicroPort Orthopedics Recalls Lineage Liners Due to Metal Debris Tissue Reaction

    MicroPort Orthopedics is recalling 5,009 Lineage Liners used with Conserve metal heads due to a suspected tissue reaction to metal debris.

    Product
    Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-12-07

    MicroPort Recalls Cobalt Chromium Hip Replacement Heads Due to Metal Debris Risk

    MicroPort Orthopedics is recalling specific Cobalt Chromium hip replacement heads because internal data showed an increasing trend in revision rates and a specific hazard of tissue reaction to metal debris.

    Product
    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…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-12-07

    MicroPort Dynasty Liners Recalled Due to Metal Debris Tissue Reaction Risk

    MicroPort Orthopedics is recalling 6,250 Dynasty Liners used in hip replacements due to an increasing trend of suspected tissue reactions to metal debris.

    Product
    Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-12-07

    MicroPort Orthopedics Recalls Conserve Cups Due to Metal Debris Tissue Reaction

    MicroPort Orthopedics is recalling Conserve Cups because revision rate trends indicate a specific hazard of tissue reaction to metal debris.

    Product
    Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-12-07

    MicroPort Lineage Shell Recalled Due to Metal Debris Tissue Reaction Risk

    MicroPort Orthopedics is recalling 22 Lineage Shell units due to an increasing trend in revision rates and a specific hazard of tissue reaction to metal debris.

    Product
    Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-12-07

    MicroPort Orthopedics Recalls Procotyl Rim-Lock Liners Due to Tissue Reaction Risk

    MicroPort Orthopedics is recalling 500 units of Procotyl Rim-Lock Liners because revision rate trends indicate a specific hazard of tissue reaction to metal debris.

    Product
    Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-12-07

    MicroPort Recalls Conserve Hip Shells Due to Metal Debris Tissue Reaction

    MicroPort Orthopedics is recalling Conserve hip shells because revision rate trends indicate a specific hazard of tissue reaction to metal debris.

    Product
    Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF…
    Category
    Distribution
    1 state