The Recall Desk

FDA (Devices) recall action 70438

Biomet, Inc. recalled 2 products on 2015-02-25

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2015-02-25
Critical
0
Units
34

Why these products were recalled

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

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

1–2 of 2

  • ModerateFDA (Devices)··2015-02-25

    Biomet Recalls Specific Lot of Mallory Head Acetabular Shell Components

    Biomet is recalling 17 units of the Mallory Head 4 Finned Acetabular Shell 50 mm (Lot 364600) due to a packaging mix-up with a different shell size.

    Product
    Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2015-02-25

    Biomet Recalls Acetabular Shell Components Due to Packaging Mix-Up

    Biomet is recalling specific acetabular shell components for hip prostheses due to a packaging mix-up between two different product lots.

    Product
    Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
    Category
    Distribution
    2 states