Recall Z-0172-2020 ยท HAW Neurological Stereotaxic Instrument
MEDTECH SAS
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.
| Date | Nov 1, 2019 (initiated Sep 10, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software in the Use Environment |
| Action | On September 10, 2019, the firm issued an Urgent Medical Device Correction to customers, advising them of the product issue. The customer notification included instructions for a workaround for the issue. Customers were also advised of the workflow that would cause the problem to occur. The firm stated that they would provide a label containing the workaround instructions that could be applied directly to the unit by September 30, 2019. A Zimmer Biomet engineer will be deployed to each customer site to implement a new software version to correct the issue. Customers will be contacted by 10/3 |
| Quantity | 93 |
| Distribution | Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam. |
| FDA record | Open on fda.gov |