The Recall Desk

FDA (Devices) recall action 62140

Exactech, Inc. recalled 6 products on 2012-09-19

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2012-09-19
Critical
0
Units
12

Why these products were recalled

Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

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

1–6 of 6

  • HighFDA (Devices)··2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-09-19

    Exactech Recalls Novation Modular Drill Bits for Non-Sterile Condition

    Exactech is recalling two Novation Modular Drill Bits after they were reported to have been used in a non-sterile condition.

    Product
    REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Issues

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-09-19

    Exactech Recalls Novation Modular Drill Bits for Sterility Issues

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique
    Category
    Distribution
    1 state