Reported Dec 26, 2018 · Terminated
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the…
Mazor Robotics Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mazor Robotics Ltd · 5 Shacham Street · North Industrial Park · N/A
Is this the product you have?
- 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 to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
- Lot codes and dates
- Affected productsall Carousels under Level 01 were affected and therefore are applicable to this issue
- The related lots include
WP065611WP066389WP066411WP066412WP066420
- Explanation of the coding systema part number (e.g. MAS1025-01) is composed of a generic part number related to the part (e.g. MAS1025) and the level of the part (e.g. 01)
- Amount recalled
- 5 units
Why it was recalled
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
This product could cause temporary or reversible health problems — stop using it.
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