The Recall Desk

FDA (Devices) recall action 83288

BioPro, Inc. recalled 21 products on 2019-08-21

The FDA (Devices) publishes a recall like this one as 21 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 21 pages.

Products
21
Announced
2019-08-21
Critical
0
Units
1,368

Why these products were recalled

Manufacturing flaw in the sterile barrier system

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

1–21 of 21

  • HighFDA (Devices)··2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 240 units of K-Wire Single Trocar 2.5x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x105 (Item 19669) due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x30 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x90 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x120 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro K-Wire Sterile Single Trochar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling K-Wire Sterile Single Trochar units due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x34 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 2.5x170mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x38 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro K-Wire HBS Sterile Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro K-Wire Sterile Single Trochar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling K-Wire Sterile Single Trochar units due to a manufacturing flaw in the sterile barrier system that may compromise sterility.

    Product
    K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x115 due to a manufacturing flaw in the sterile barrier system. The devices are intended for orthopedic surgical procedures.

    Product
    Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro K-Wire HBS Sterile Lots Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile Lots due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x110 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x100 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x36 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x95 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x85 due to a manufacturing flaw in the sterile barrier system. The devices were distributed in the US and internationally.

    Product
    Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.6x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x32 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.1x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Distribution
    7 states