Cranial tracker devices recalled over an error message preventing use
Howmedica Osteonics is recalling 320 Stryker CranialMask Trackers because activating the device during surgery produces an error message that makes the device unusable.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated effect is an inability to use the device, with no patient harm or reported injury.
Plain-English summary
The Stryker CranialMask Tracker is being recalled by Howmedica Osteonics Corp. The record describes it as a single-use device consisting of a flexible printed circuit board with 31 infrared light-emitting diodes and an electronics control unit with its own battery power supply.
When the device is activated during surgery, the device software issues an error message reading "Instrument Face Mask (6001385000000) is not valid for this application", resulting in an inability to use the device.
The record lists 320 units, part number 6000-390-000, UDI-DI 37613327097628, from lots 6000106885, 6000106894, 6000106895 and 6000106896. Distribution was worldwide, including nationwide in the United States and to Canada, Germany, Japan and South Korea. The FDA has classified the action as Class II.
The record describes an inability to use the device and states no further consequence or reported injuries. Facilities should follow the firm's instructions.
The recalled product
- 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…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Part Number: 6000-390-000
- UDI-DI: 37613327097628
- Lots: 6000106885
- 6000106894
- 6000106895
- 6000106896
Distribution
Distributed nationwide across the United States.
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