Augmedics Perc Pin Adaptor component recalled due to design defect
Augmedics Ltd. is recalling the Perc Pin Adaptor, a component of the xvision Spine surgical navigation system, because the tightening knob is inconvenient to use and the tightening markings are improperly placed.
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a design inconvenience (improper knob tightening and marking placement) that does not present an immediate risk of serious adverse health consequences.
Plain-English summary
Augmedics Ltd. is recalling the Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system. The xvision Spine is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately during open or percutaneous computer-assisted spinal surgery.
The perc pin adaptor tightening knob was found to be inconvenient to the user, and the tightening markings were found to be improperly placed. Approximately 85 units were distributed nationwide in the United States.
Patients or healthcare providers who have this device should contact Augmedics Ltd. for further instructions regarding replacement or return of the affected component. Healthcare facilities should review their inventory for affected lot numbers ranging from 038110 to 054926.
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
- design-defect
- user-inconvenience
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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