The Recall Desk

FDA (Devices) recall action 77252

DePuy Mitek, Inc., a Johnson & Johnson Co. recalled 5 products on 2017-06-28

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2017-06-28
Critical
0
Units
809

Why these products were recalled

Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

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

1–5 of 5

  • HighFDA (Devices)··2017-06-28

    DePuy Mitek LATARJET Extraction Driver Recalled for Breakage Risk

    DePuy Mitek is recalling 115 units of the LATARJET EXPERIENCE Extraction Driver because the tip may break during surgery when used at an angle.

    Product
    DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Distribution
    8 states
  • SevereFDA (Devices)··2017-06-28

    DePuy Mitek LATARJET Drill Tip Recall Due to Breakage Risk

    DePuy Mitek is recalling LATARJET Coracoid Top Hat Drills because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Distribution
    8 states
  • SevereFDA (Devices)··2017-06-28

    DePuy Mitek LATARJET Coracoid Drill Recalled for Breakage Risk

    DePuy Mitek is recalling LATARJET Coracoid Drills because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2017-06-28

    DePuy Mitek LATARJET Combo Screw Driver Recalled for Breakage Risk

    DePuy Mitek is recalling 173 LATARJET Combo Screw Drivers because the tip may break during surgery when used at an angle.

    Product
    DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2017-06-28

    DePuy Mitek Top Hat Tap Screw Driver Tip Recall

    DePuy Mitek is recalling 153 units of the LATARJET EXPERIENCE Top Hat Tap because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Distribution
    8 states