The Recall Desk

FDA (Devices) recall action 63358

Stryker Howmedica Osteonics Corp. recalled 2 products on 2012-11-28

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
2012-11-28
Critical
0
Units
430

Why these products were recalled

Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.

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

  • ModerateFDA (Devices)··2012-11-28

    Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up

    Stryker Howmedica Osteonics is recalling approximately 72 units of 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length.

    Product
    Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-11-28

    Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up

    Stryker is recalling 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length, potentially leading to incorrect surgical fixation.

    Product
    Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent…
    Category
    Distribution
    0 states