The Recall Desk

FDA (Devices) recall action 71676

Stryker Howmedica Osteonics Corp. recalled 5 products on 2015-08-26

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2015-08-26
Critical
0
Units
84,960

Why these products were recalled

Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.

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.

1–5 of 5

  • ModerateFDA (Devices)··2015-08-26

    Stryker Recalls Radio-Capitellum Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific Radio-Capitellum implants because transportation may have compromised the sterile barrier of the packaging.

    Product
    Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-08-26

    Stryker Recalls uHead and Other Ulnar Implants Due to Packaging Concerns

    Stryker is recalling specific ulnar implants because the sterile packaging may be compromised by transportation.

    Product
    uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-08-26

    Stryker Recalls Sigmoid Notch Radial Plates Due to Packaging Integrity Concerns

    Stryker is recalling Sigmoid Notch Radial Plates because the sterile packaging barrier may be compromised during transportation.

    Product
    Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-08-26

    Stryker Recalls rHead and uHead Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific rHead, uHead, and other radial implants because their sterile packaging may be compromised by transportation.

    Product
    rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-08-26

    Stryker Recalls Wrist Implants Due to Potential Sterile Barrier Compromise

    Stryker is recalling specific wrist implant models because their sterile packaging may be compromised during transportation.

    Product
    Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
    Category
    Distribution
    0 states