The Recall Desk

FDA (Devices) recall action 74727

Stryker Howmedica Osteonics Corp. recalled 2 products on 2016-09-21

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
2016-09-21
Critical
0
Units
2

Why these products were recalled

Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

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)··2016-09-21

    Stryker Recalls Mislabelled Femoral and Tibial Nails

    Stryker Howmedica Osteonics Corp. is recalling specific femoral and tibial nails that were incorrectly labeled and distributed to California.

    Product
    Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and corr
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-09-21

    Stryker Recalls Mislabelled T2 Supracondylar Nail System

    Stryker Howmedica Osteonics Corp. is recalling one unit of the T2 Supracondylar Nail System because it was incorrectly labeled and distributed.

    Product
    Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Patholo
    Category
    Distribution
    1 state