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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · surgical injury
See all →- HighSTERIS Boot Assembly, Traction Device Recalled Due to Locking Pin Detachment Risk
FDA (Devices) · 2024-03-20
- HighIn2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use
FDA (Devices) · 2021-03-31
- HighSmith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments
FDA (Devices) · 2020-06-03
- SevereK2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk
FDA (Devices) · 2020-05-27
- SevereK2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
FDA (Devices) · 2020-05-27