Z-0115-2018 Class II Terminated
FDA device recall Z-0115-2018 was initiated by Zimmer Biomet, Inc. on Apr 8, 2016 and is designated Class II. Reason for recall: Potential for software to change the final tool orientation for the command position without command. The recall status is terminated (terminated Jul 13, 2020). Affected quantity: 64 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 29, 2017
- Initiation Date
- Apr 8, 2016
- Termination Date
- Jul 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 units
Product Description
ROSA Surgical Device 2.5.8
Reason for Recall
Potential for software to change the final tool orientation for the command position without command.
Distribution Pattern
AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom
Code Information
Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0115-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026