Zimmer Biomet Recalls ROSA Spine Stereotaxic Instrument Due to Positioning Error
Zimmer Biomet is recalling one ROSA Spine 1.0.2 Stereotaxic instrument because the robot arm may move to the wrong position during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a surgical device defect that could lead to significant injury during a procedure, meeting the criteria for a Severe rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling one unit of the ROSA Spine 1.0.2 Stereotaxic instrument, a computer-assisted surgical device intended for the spatial positioning and orientation of instrument holders used by surgeons. The recall is being conducted because the device's robot arm may be sent to the wrong position.
The affected unit, identified by code SP16008, was distributed to facilities in California, the District of Columbia, Florida, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, and Pennsylvania.
This is an FDA Class II recall. Healthcare facilities that have this device should contact Zimmer Biomet for instructions on how to stop using the device and arrange for its return or repair.
The recalled product
- Product
- 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.
- Manufacturer
- Zimmer Biomet, Inc.
- 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)
- 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.
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