Z-0178-2018 Class II Terminated
FDA device recall Z-0178-2018 was initiated by Zimmer Biomet, Inc. on Feb 10, 2013 and is designated Class II. Reason for recall: Issue with optional neuro-endoscopy module detected under specific conditions during internal testing. The recall status is terminated (terminated Jun 9, 2020). Affected quantity: 22 units (4 US and 18 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Dec 6, 2017
- Initiation Date
- Feb 10, 2013
- Termination Date
- Jun 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units (4 US and 18 OUS)
Product Description
ROSA Surgical Device 2.5.8
Reason for Recall
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
Distribution Pattern
AR, OH, MI, and TX
Code Information
Serial No. RO10011, RO10014, RO13023 and RO13027
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0178-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026