The Recall Desk

FDA (Devices) recall action 73091

Richard Wolf Medical Instruments Corp. recalled 3 products on 2016-02-17

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-02-17
Critical
0
Units
2

Why these products were recalled

Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.

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

1–3 of 3

  • HighFDA (Devices)··2016-02-17

    Richard Wolf Reusable Rotary Blade Recall Due to Weak Welds

    Richard Wolf Medical Instruments Corp. is recalling ten reusable rotary blade/abrader units due to weak welds that may cause the product to break during surgical use.

    Product
    Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-02-17

    Richard Wolf Reusable Rotary Blade Recalled for Weak Welds

    Richard Wolf Medical Instruments Corp. is recalling two reusable rotary blades due to weak welds that may cause the product to break during surgical use.

    Product
    Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-02-17

    Richard Wolf Reusable Rotary Blade Recalled for Weak Welds

    Richard Wolf Medical Instruments Corp. is recalling four reusable rotary blade/abrader units due to weak welds that may cause the product to break during surgical use.

    Product
    Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
    Category
    Distribution
    1 state