CLASS II Device recall · Reported 6 Dec 2017 · FDA Enforcement Report

ROSA Surgical Device recalled by Zimmer Biomet

Zimmer Biomet is recalling ROSA Surgical Device 5.8, distributed in Arkansas, Michigan, Ohio, Texas. The recall was initiated on 10 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. RO10011, RO10014, RO13023 and RO13027

Quantity recalled22 units (4 US and 18 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-0178-2018
FDA event ID: 77672
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 10 Feb 2013
FDA classified: 28 Nov 2017
Reported: 6 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

10 Feb 2013	Recall initiated by company
28 Nov 2017	Classified by FDA	+1752 days
6 Dec 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

Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.

Product as listed by the FDA

ROSA Surgical Device 2.5.8

Where it was distributed

AR, OH, MI, and TX

Arkansas Michigan Ohio Texas

Questions about this recall

Is ROSA Surgical Device 5.8 recalled?

Yes. Zimmer Biomet recalled ROSA Surgical Device 5.8 on 10 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-0178-2018.

Why was it recalled?

Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.

Which lots are affected?

Serial No. RO10011, RO10014, RO13023 and RO13027

Where was it sold?

AR, OH, MI, and TX

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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