Zimmer Biomet Recalls MEDTECH ROSA Spine Software Due to Unapproved Change
Zimmer Biomet is recalling MEDTECH ROSA Spine 1.0.2 software because an unapproved change was made by the supplier. The device is used to guide instruments during spine surgery.
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, and the source text does not report any illnesses, injuries, or deaths. The hazard is an unapproved change by the supplier, which fits the criteria for a moderate severity recall involving potential quality or compliance issues without reported harm.
Plain-English summary
Zimmer Biomet, Inc. is recalling one unit of MEDTECH ROSA Spine 1.0.2 software. The device is intended for the spatial positioning and orientation of instrument holders or tool guides used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. It is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.
The recall was initiated because an unapproved change was made by the supplier. The affected unit has the serial number SP16008.
The product was distributed nationwide to California, Florida, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Pennsylvania, and the District of Columbia. Users should contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- MEDTECH ROSA Spine 1.0.2 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 during spine surgery. Guidance is based on an intra-operative plan developed w
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1
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 (1)
- Serial #'s: SP16008
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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