Z-2868-2017 Class II Terminated
FDA device recall Z-2868-2017 was initiated by Zimmer Biomet, Inc. on Oct 11, 2016 and is designated Class II. Reason for recall: Complaint of the head holder connector locking up mechanically when tightened. The recall status is terminated (terminated Jun 29, 2020). Affected quantity: 20 units (16 US, 4 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 9, 2017
- Initiation Date
- Oct 11, 2016
- Termination Date
- Jun 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units (16 US, 4 OUS)
Product Description
ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Reason for Recall
Complaint of the head holder connector locking up mechanically when tightened.
Distribution Pattern
Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France
Code Information
Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16024.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2868-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026