The Recall Desk

FDA (Devices) recall action 84865

Aesculap Implant Systems LLC recalled 5 products on 2020-03-25

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2020-03-25
Critical
0
Units
24,010

Why these products were recalled

Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

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

1–5 of 5

  • HighFDA (Devices)··2020-03-25

    Aesculap Recalls Knee Implants Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low density polyethylene particles may be present on the surface.

    Product
    COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z Product Usage:
    Category
    Distribution
    24 states
  • HighFDA (Devices)··2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus CR/PS Tibial Plateau knee implant components because low-density polyethylene particles may be present on the surface.

    Product
    COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there a
    Category
    Distribution
    24 states
  • HighFDA (Devices)··2020-03-25

    Aesculap Columbus Knee Implant Components Recalled for LDPE Particles

    Aesculap is recalling Columbus R/PS Tibia Plateau knee implant components because low-density polyethylene particles may be present on the surface upon opening.

    Product
    Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant
    Category
    Distribution
    24 states
  • HighFDA (Devices)··2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus knee implant components because low-density polyethylene particles may be present on the surface when the packaging is opened.

    Product
    COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these impla
    Category
    Distribution
    24 states
  • HighFDA (Devices)··2020-03-25

    Aesculap Recalls Knee Implant Components Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low-density polyethylene particles may be present on the surface upon opening.

    Product
    AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Pl
    Category
    Distribution
    24 states