FDA (Devices) recall action 85583
The FDA (Devices) publishes a recall like this one as 16 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 16 pages.
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
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.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post in the inner packaging, resulting in loose coating debris.
Howmedica Osteonics is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in loose coating debris.
Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post in the inner packaging, resulting in coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may detach from its post within the inner packaging, resulting in loose components and coating debris.
Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may fall off its post in the inner packaging, resulting in loose coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their post in packaging, resulting in loose devices with coating debris.
Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their posts within the inner packaging, resulting in loose devices and coating debris.
Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may detach from its post inside the packaging, resulting in loose coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their post within the inner packaging, resulting in loose devices and coating debris.