Z-0102-2018 Class II Terminated
FDA device recall Z-0102-2018 was initiated by Zimmer Biomet, Inc. on Feb 14, 2014 and is designated Class II. Reason for recall: An undetected shift between the information displayed in the navigation software and the actual patient anatomy The recall status is terminated (terminated Sep 16, 2020). Affected quantity: 21 (4 US and 17 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 22, 2017
- Initiation Date
- Feb 14, 2014
- Termination Date
- Sep 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 (4 US and 17 OUS)
Product Description
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
Reason for Recall
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Distribution Pattern
OH, MI and TX
Code Information
Serial #s; RO10009, RO10011, RO10014, and RO13023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0102-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026