The Recall Desk

FDA (Devices) recall action 69360

Biomet, Inc. recalled 3 products on 2014-10-15

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
2014-10-15
Critical
0
Units
191

Why these products were recalled

An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.

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

  • SevereFDA (Devices)··2014-10-15

    Biomet Recalls Mamba Disposable Nitinol Needles Due to Breakage Risk

    Biomet is recalling 164 Mamba Disposable Nitinol Needles because high friction may cause the needles to break during use.

    Product
    Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2014-10-15

    Biomet Recalls Green Mamba Suture Passers Due to Needle Breakage Risk

    Biomet, Inc. is recalling 12 units of Green Mamba Suture Passers because high friction may cause the needle to break during use.

    Product
    Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2014-10-15

    Biomet Black Mamba Suture Passer Recalled Due to Needle Breakage Risk

    Biomet, Inc. is recalling 15 units of Black Mamba Suture Passers because high friction may cause the needle to break during use.

    Product
    Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Distribution
    13 states