Device product

ROSA BRAIN 3.0.0

Z-0116-2018

July 29, 2016

Class II

Product summary

Firm: Zimmer Biomet, Inc.
Event: Event 77741
Status: Terminated
Classification: Class II
Quantity: 2 devices
Official record key: device-enforcement:Z-0116-2018

Official wording

Reason: Non-conforming product label.

Code information: Serial No. BR16017 and BR16018

Distribution pattern: OH and PA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Non-conforming product label.