PlainRecalls
FDA Devices Moderate Class II Terminated

ROSA Surgical Device 2.5.8

Reported: December 6, 2017 Initiated: February 10, 2013 #Z-0178-2018

Product Description

ROSA Surgical Device 2.5.8

Reason for Recall

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

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
22 units (4 US and 18 OUS)
Distribution
AR, OH, MI, and TX
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
ROSA Surgical Device 2.5.8. Recalled by Zimmer Biomet, Inc.. Units affected: 22 units (4 US and 18 OUS).
Why was this product recalled?
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 6, 2017. Severity: Moderate. Recall number: Z-0178-2018.