The Recall Desk

FDA (Devices) recall action 63612

Biomet, Inc. recalled 2 products on 2012-12-12

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
2012-12-12
Critical
0
Units
82

Why these products were recalled

Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

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.

1–2 of 2

  • HighFDA (Devices)··2012-12-12

    Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Risk

    Biomet is recalling 46 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.

    Product
    OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-12-12

    Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Defect

    Biomet is recalling 36 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.

    Product
    OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
    Category
    Distribution
    0 states