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Terminated

ROSA BRAIN 3.0.0

FDA Recall Z-0116-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2016-07-29
Date Terminated2020-06-16
Product Quantity2 devices

Reason for Recall

Non-conforming product label.

Firm Action

All affected devices received a corrected label. Correction notification and implementation were performed by field technicians.

Root Cause

Error in labeling

Distribution Pattern

OH and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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