Howmedica Osteonics Corp. Recall: The Stryker CranialMask Tracker is a single-use device c
Howmedica Osteonics Corp. Recall: The Stryker CranialMask Tracker is a single-use device c is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Howmedica Osteonics Corp.; Product: The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) wit
| Recalling firm | Howmedica Osteonics Corp. |
|---|---|
| Product | The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration. |
| Reason for recall | When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea. |
| Recall initiated | 20251112 |
| Recall number | Z-0963-2026 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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