RecallRadar

FDA Device recall Z-0178-2018

ROSA Surgical Device 2.5.8

On 2017-12-06 the FDA classified a Class II recall of ROSA Surgical Device 2.5.8 by Zimmer Biomet, citing issue with optional neuro-endoscopy module detected under specific conditions during internal testing.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0178-2018
ClassificationClass II
Statusterminated
Initiated2013-02-10
Published2017-12-06
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
DistributionAR, MI, OH, TX

Product

ROSA Surgical Device 2.5.8

Reason

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

Identifiers

code_infoSerial No. RO10011, RO10014, RO13023 and RO13027

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0178-2018%22

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