CLASS I Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

Rosa Brain recalled by Medtech Sas

Medtech Sas is recalling Rosa Brain 0, distributed nationwide in the US. The recall was initiated on 10 Sep 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesBR16004 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

Quantity recalled93

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0172-2020
FDA event ID: 83665
Recalling firm: Medtech Sas, Montpellier, N/A
Classification: Class I
Status: Terminated
Recall initiated: 10 Sep 2019
FDA classified: 1 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Hip & Knee Implants

Timeline

10 Sep 2019	Recall initiated by company
1 Nov 2019	Classified by FDA	+52 days
13 Nov 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Stores named: Target

Questions about this recall

Is Rosa Brain 0 recalled?

Yes. Medtech Sas recalled Rosa Brain 0 on 10 Sep 2019. The recall is Class I and its status is Terminated. Recall number Z-0172-2020.

Why was it 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 lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtech Sas

All 5

Reported	Class	Recall	Company	Reason	Where
3 Nov 2021Device	CLASS I	ROSA One 1 Brain application The device is intended recalled	Medtech Sas	Labeling Errors	Nationwide
19 Feb 2020Device	CLASS II	ROSA One 1 Brain Application recalled by Medtech Sas	Medtech Sas	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	ROSA Brain 0 Application-Brain recalled by Medtech Sas	Medtech Sas	Device Malfunction	Nationwide
13 Jun 2018Device	CLASS II	ROSA(TM) Robotized Stereotactic Assistant recalled by Medtech Sas	Medtech Sas	Device Malfunction	N/A

Other Hip & Knee Implants recalls

All 3,097

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26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
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12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide