Mazor Robotics Recalls Carousel Accessories for Brain and Spinal Surgery Kits
Mazor Robotics is recalling five Carousel MAS1025-01 units used in brain and spinal surgery kits because the position pin may fail, causing the carousel to move inadvertently.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used during surgery where a mechanical failure could lead to patient harm, but the source text does not report any injuries or illnesses, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mazor Robotics Ltd is recalling five units of the Carousel MAS1025-01, which is part of the Brain Surgical Accessories Intra-operative Kit (KIT0295) and used with the Renaissance System (TPL0038). These accessories are indicated for the precise positioning of surgical instruments or spinal implants during general spinal and brain surgery.
The recall was initiated because, in some situations, the carousel position pin (locker) may cause the carousel upper plate to pop out. This failure can result in the carousel inadvertently moving during use. The affected products include all Carousels under Level 01, specifically associated with lots WP065611, WP066389, WP066411, WP066412, and WP066420.
The affected devices were distributed in the United States to four different medical facilities in four states. The source text does not report any specific injuries or illnesses associated with this defect. Medical facilities should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended t
- Manufacturer
- Mazor Robotics Ltd
- Affected units
- 5
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 (3)
- WP066389
- WP066411
- WP066412
Distribution
Distribution scope not specified by the agency.
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