Spine Surgery Navigation Adaptor Recalled for Inconvenient Knob Design
Augmedics is recalling the Perc Pin Adaptor component of spine surgery guidance systems due to an inconvenient tightening knob and improperly placed markings.
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: This is an FDA Class II recall with no reported illnesses, injuries, or demonstrated harm. The defect involves user inconvenience and improper marking placement in a surgical device design, representing a design-quality issue rather than a direct patient safety threat.
Plain-English summary
Augmedics Ltd. is recalling the Perc Pin Adaptor, Model AMCH07200, a component of the xvision Spine (XVS) image-guided navigation system designed to assist surgeons in placing pedicle screws during spinal surgery. The recall was initiated because the adaptor's tightening knob is inconvenient to operate and the tightening markings are improperly positioned.
Approximately 85 units of the affected adaptor were distributed nationwide. The affected product can be identified by UDI 07290113780910 and lot numbers 038110 through 054926.
Augmedics is notifying hospitals and surgical centers that received the affected adaptors. Healthcare providers and facilities with the affected component should contact Augmedics for further guidance on replacement or remediation options.
The recalled product
- Product
- Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
- Manufacturer
- Augmedics Ltd.
- Hazard
- usability-flaw
- labeling-error
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)
- UDI: 07290113780910
- Lot Numbers: 038110 to 054926
Distribution
Distributed nationwide across the United States.
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