CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report

ROSA(TM) Robotized Stereotactic Assistant recalled by Medtech Sas

Medtech Sas is recalling ROSA(TM) Robotized Stereotactic Assistant. The recall was initiated on 8 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: RO 10 009, RO 10 011, RO 10 014, RO 13 023, RO 13 027, RO 14 031, RO 14 033, RO 14 035, RO 14 038, RO 14 039, RO 14 040, RO 14 041, RO 14 043, RO 15 044, RO 15 045, RO 15 046, RO 15 050, RO 15 051, RO 15 052, RO 15 053, RO 15 054, RO 15 058, RO 15 059, RO 15 060, RO 15 061, RO 15 063, RO 15 064, RO 15 067, RO 15 069

Quantity recalled29 units

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-2108-2018
FDA event ID: 80061
Recalling firm: Medtech Sas, Montpellier, N/A
Classification: Class II
Status: Terminated
Recall initiated: 8 May 2018
FDA classified: 7 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

8 May 2018	Recall initiated by company
7 Jun 2018	Classified by FDA	+30 days
13 Jun 2018	Published in enforcement report	+6 days

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

Reason for recall

Replacement of units lacking an updated device approval.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

Where it was distributed

US Distribution

Questions about this recall

Is ROSA(TM) Robotized Stereotactic Assistant recalled?

Yes. Medtech Sas recalled ROSA(TM) Robotized Stereotactic Assistant on 8 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2108-2018.

Why was it recalled?

Replacement of units lacking an updated device approval.

Which lots are affected?

Serial Numbers: RO 10 009, RO 10 011, RO 10 014, RO 13 023, RO 13 027, RO 14 031, RO 14 033, RO 14 035, RO 14 038, RO 14 039, RO 14 040, RO 14 041, RO 14 043, RO 15 044, RO 15 045, RO 15 046, RO 15 050, RO 15 051, RO 15 052, RO 15 053, RO 15 054, RO 15 058, RO 15 059, RO 15 060, RO 15 061, RO 15 063, RO 15 064, RO 15 067, RO 15 069

Where was it sold?

US Distribution

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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 Nov 2019Device	CLASS I	Rosa Brain recalled by Medtech Sas	Medtech Sas	Foreign Material	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide