Z-0160-2018 Class II Terminated
FDA device recall Z-0160-2018 was initiated by Zimmer Biomet, Inc. on Nov 6, 2014 and is designated Class II. Reason for recall: Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended). The recall status is terminated (terminated Jul 13, 2020). Affected quantity: 31 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 29, 2017
- Initiation Date
- Nov 6, 2014
- Termination Date
- Jul 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 units
Product Description
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Reason for Recall
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Distribution Pattern
US distribution in AR, GA, OH, MI, and TX.
Code Information
Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0160-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026