The Recall Desk

FDA (Devices) recall action 80921

Biomet UK Ltd. recalled 4 products on 2018-10-03

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-10-03
Critical
0
Units
61

Why these products were recalled

HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel

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

1–4 of 4

  • HighFDA (Devices)··2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates Due to Fit Issues

    Biomet UK Ltd. is recalling 10 units of HipLOC Hip Fracture Fixation System plates due to an undersized bore that prevents the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling 44 units of the HipLOC Hip Fracture Fixation System due to an undersized bore that may prevent the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fix
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling 6 units of HipLOC System 140° Plates due to an undersized bore that prevents the lag screw from fitting through the barrel.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling specific HipLOC hip fracture fixation system plates due to an undersized bore that prevents the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
    Category
    Distribution
    4 states