Z-0116-2018 Class II Terminated
FDA device recall Z-0116-2018 was initiated by Zimmer Biomet, Inc. on Jul 29, 2016 and is designated Class II. Reason for recall: Non-conforming product label. The recall status is terminated (terminated Jun 16, 2020). Affected quantity: 2 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 29, 2017
- Initiation Date
- Jul 29, 2016
- Termination Date
- Jun 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 devices
Product Description
ROSA BRAIN 3.0.0
Reason for Recall
Non-conforming product label.
Distribution Pattern
OH and PA.
Code Information
Serial No. BR16017 and BR16018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0116-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026