Z-1508-2016 Class II Terminated
FDA device recall Z-1508-2016 was initiated by Mako Surgical Corporation on Apr 30, 2014 and is designated Class II. Reason for recall: Revision of the field manual The recall status is terminated (terminated Jul 24, 2019). Affected quantity: 249.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 27, 2016
- Initiation Date
- Apr 30, 2014
- Termination Date
- Jul 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 249
Product Description
Robotic Arm Interactive Orthopedic System (RIO)
Reason for Recall
Revision of the field manual
Distribution Pattern
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.
Code Information
Catalog # 203900 & 207092 All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1508-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026