The Recall Desk

FDA (Devices) recall action 83637

Aesculap Implant Systems LLC recalled 2 products on 2019-09-18

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-09-18
Critical
0
Units
—

Why these products were recalled

possibility of the sterility batch being insufficiently sterilized

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

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2019-09-18

    Aesculap Caiman Disposable Surgical Instrument Recalled for Sterility Concerns

    Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility that the sterility batch was insufficiently sterilized.

    Product
    CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-09-18

    Aesculap Caiman Disposable Surgical Instruments Recalled for Sterility Concerns

    Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility of insufficient sterilization.

    Product
    CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
    Category
    Distribution
    1 state