ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Reported: February 28, 2018 Initiated: May 1, 2017 #Z-0638-2018
Product Description
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Reason for Recall
Robot arm being sent to the wrong position
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 16
- Distribution
- Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.. Recalled by Zimmer Biomet, Inc.. Units affected: 16.
Why was this product recalled? ▼
Robot arm being sent to the wrong position
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2018. Severity: Moderate. Recall number: Z-0638-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11