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 instrument holders or tool guides to be used by neurosurgeons.
Reported: November 13, 2019 Initiated: September 10, 2019 #Z-0172-2020
Product Description
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 instrument holders or tool guides to be used by neurosurgeons.
Reason for Recall
The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
Details
- Recalling Firm
- MEDTECH SAS
- Units Affected
- 93
- Distribution
- Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam.
- Location
- Montpellier, N/A
Frequently Asked Questions
What product was recalled? ▼
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 instrument holders or tool guides to be used by neurosurgeons.. Recalled by MEDTECH SAS. Units affected: 93.
Why was this product recalled? ▼
The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Critical. Recall number: Z-0172-2020.
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