Carousel MAS1025-01 recall
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038).…
Why was Carousel MAS1025-01 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Affected products: all Carousels under Level 01 were affected and therefore are applicable to this issue. The related lots include: WP065611, WP066389, WP066411, WP066412, WP066420. Explanation of the coding system: a 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).
- Product
- Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038).…
- Recalling firm
- Mazor Robotics Ltd
- Quantity
- 5 units
- Distribution
- Affected devices were distributed in the US to four different medical facilities in four states
- Recall date
- December 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)