ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Reported: February 28, 2018 Initiated: May 1, 2017 #Z-0639-2018
Product Description
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Reason for Recall
Robot arm being sent to the wrong position
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 1
- 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 Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.. Recalled by Zimmer Biomet, Inc.. Units affected: 1.
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-0639-2018.
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