Medtech Rosa Brain 3.0 Neurosurgical Device Recalled for Trajectory Errors
Medtech SAS is recalling 93 Rosa Brain 3.0 neurosurgical devices because the instrument holder may send tools on incorrect trajectories, potentially leading to improper device placement.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class I, which mandates a minimum score of 4. Additionally, the defect involves a structural/mechanical failure in a neurosurgical device that could lead to significant injury if the device is placed incorrectly.
Plain-English summary
Medtech SAS is recalling 93 units of the Rosa Brain 3.0, Model No. ROSA 3.0, a medical device intended for the spatial positioning and orientation of instrument holders or tool guides used by neurosurgeons. The device is delivered assembled in a wooden case and is not shipped sterile.
The recall is due to a defect where the instrument holder may be sent on a trajectory that is not within the intended target. If this issue is not corrected, the associated device may be placed incorrectly during use.
The affected units were distributed domestically nationwide and internationally to Australia, France, Switzerland, Taiwan, and Vietnam. Specific lot codes for the 93 units are listed in the official recall documentation. Users of these devices should contact Medtech SAS for instructions on how to proceed.
The recalled product
- Product
- Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of inst
- Manufacturer
- MEDTECH SAS
- Affected units
- 93
Distribution
Distributed nationwide across the United States.
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