The Recall Desk

FDA (Devices) recall action 90537

Aesculap Implant Systems LLC recalled 2 products on 2022-07-27

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
2022-07-27
Critical
0
Units
4

Why these products were recalled

Customized coronal rod benders may deform the implant when used with the spinal system devices.

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

1–2 of 2

  • HighFDA (Devices)··2022-07-27

    Surgical Coronal Bender May Deform Spinal Implants During Surgery

    Aesculap's coronal rod benders used in spinal surgery may deform implants during use. A Class II recall affects 2 units in Colorado.

    Product
    RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2022-07-27

    Spinal Surgery Instrument Recall: LEFT CORONAL BENDER May Deform Implants

    Aesculap Implant Systems LLC is recalling the LEFT CORONAL BENDER (TEK1939) surgical instrument used in spinal procedures because it may deform implants when used with spinal system devices.

    Product
    LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
    Category
    Distribution
    1 state