Howmedica Osteonics Corp. (Stryker) is recalling 320 units of the Stryker CranialMask Tracker due to a software error. When activated during surgery, the device may display an error message stating the face mask is invalid, which prevents the tracker from functioning. This failure can result in an inability to use the device during critical navigated surgical procedures.
The device software issues an error that makes the tracking system unusable mid-surgery, which can lead to surgical delays or the loss of guided navigation for surgeons.
Quantity: 320 units
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Sources: FDA iRES · Raw API Response
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