The Recall Desk

FDA (Devices) recall action 67618

Biomet, Inc. recalled 3 products on 2014-03-26

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2014-03-26
Critical
0
Units
17

Why these products were recalled

Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly.

Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.

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

1–3 of 3

  • ModerateFDA (Devices)··2014-03-26

    Biomet Recalls Intramedullary Bone Saw CAM Assembly Due to Labeling Error

    Biomet, Inc. is recalling specific lots of the Intramedullary Bone Saw CAM Assembly because the Saw Blade Assembly was incorrectly identified as a CAM Assembly.

    Product
    Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-03-26

    Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Labeling Error

    Biomet is recalling 10 Intramedullary Bone Saw Cam Assemblies because they were incorrectly labeled as Saw Blade Assemblies.

    Product
    Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-03-26

    Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Labeling Error

    Biomet, Inc. is recalling specific lots of Intramedullary Bone Saw Cam Assemblies because they were incorrectly labeled as Saw Blade Assemblies.

    Product
    Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
    Category
    Distribution
    3 states