MEDTECH SAS: Medical Device Recall in 2019 - (Recall #: Z-0172-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: September 10, 2019

Date Posted: November 13, 2019

Recall Number: Z-0172-2020

Event ID: 83665

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.

Status: Terminated

Product Quantity: 93

Code Information:

BR16004 BR16005 BR16006 BR16009 BR16010 BR16011 BR16012 BR16012 BR16014 BR16015 BR16016 BR16017 BR16018 BR16021 BR16023 BR16025 BR17030 BR17034 BR17035 BR17036 BR17037 BR18024 BR18031 BR18038 BR18039 BR18040 BR18041 BR18042 BR18043 BR18045 BR18046 BR18047 BR18048 BR18049 BR18050 BR18051 BR18052 BR18053 BR18054 BR18055 BR18056 BR18057 BR18058 BR18059 BR18060 BR18061 BR18062 BR18063 BR18064 BR18065 BR18066 BR18067 BR18068 BR18069 BR18070 BR18071 BR18072 BR18073 BR18074 BR18075 BR18076 BR18077 BR18078 BR18079 BR18080 BR18081 BR18082 BR18083 BR18084 BR18085 BR18086 BR18087 BR18088 BR18089 BR18090 BR18091 BR18092 BR18093 BR18094 BR18095 BR18096 BR18097 BR18098 BR18099 BR18100 BR18101 BR15002 BR15003 BR16019 BR16028 BR16029 BR16026 BR16032

Distribution Pattern:

Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated