CLASS II Device recall · Reported 29 Nov 2017 · FDA Enforcement Report

ROSA Surgical Device 5.8 It is intended to be used recalled

Zimmer Biomet is recalling ROSA Surgical Device 5.8 It is intended to be used in the operating room for the spatial, distributed nationwide in the US. The recall was initiated on 4 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020.

Quantity recalled29 devices(8 US and 21 OUS)

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-0161-2018
FDA event ID: 77750
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2014
FDA classified: 21 Nov 2017
Reported: 29 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

4 Jun 2014	Recall initiated by company
21 Nov 2017	Classified by FDA	+1266 days
29 Nov 2017	Published in enforcement report	+8 days

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

Reason for recall

Software corrections reactivating the cooperative endoscopy mode.

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 Surgical Device 2.5.8 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

Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.

Nationwide Arkansas Georgia Michigan Ohio Texas

Questions about this recall

Is ROSA Surgical Device 5.8 It is intended to be used in the operating room for the spatial recalled?

Yes. Zimmer Biomet recalled ROSA Surgical Device 5.8 It is intended to be used in the operating room for the spatial on 4 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-0161-2018.

Why was it recalled?

Software corrections reactivating the cooperative endoscopy mode.

Which lots are affected?

Serial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020.

Where was it sold?

Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.

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.

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