FDA (Devices) recall action 71676
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.
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.
Stryker Howmedica Osteonics Corp. is recalling specific rHead, uHead, and other radial implants because their sterile packaging may be compromised by transportation.
Stryker is recalling Sigmoid Notch Radial Plates because the sterile packaging barrier may be compromised during transportation.
Stryker is recalling specific ulnar implants because the sterile packaging may be compromised by transportation.
Stryker is recalling specific wrist implant models because their sterile packaging may be compromised during transportation.
Stryker Howmedica Osteonics Corp. is recalling specific Radio-Capitellum implants because transportation may have compromised the sterile barrier of the packaging.