Zimmer Biomet Recalls Two Rosa Spine Stereotaxic Devices for Software Bugs
Zimmer Biomet is recalling two Rosa Spine 1.0.2 devices worldwide to resolve software bugs and improve stability.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software update to resolve bugs and improve stability without reporting any injuries, illnesses, or specific safety hazards. This aligns with the rubric for voluntary precautionary recalls or minor issues where risk of harm is not explicitly reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling two units of the Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device. The affected units have serial numbers SP14003 and SP14005. These devices are intended for the spatial positioning and orientation of instrument holders or tool guides to guide standard neurosurgical instruments during spine surgery, specifically for the placement of pedicle screws in lumbar vertebrae with a posterior approach.
The recall was initiated to update the device software from version 1.0.2 to version 1.0.2.16. This design change aims to resolve software bugs and improve the usability and stability of the ROSA Spine device. The affected units were distributed worldwide, including in France and Germany.
Healthcare facilities and users should contact Zimmer Biomet for instructions on how to update the software or replace the devices as necessary. No specific instructions for end-consumers are provided in the source text, as the device is intended for professional surgical use.
The recalled product
- Product
- Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial #'s
- SP14003 and SP14005
Distribution
Distribution scope not specified by the agency.
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