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.

Reason: In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.

Code information: 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).

Distribution pattern: Affected devices were distributed in the US to four different medical facilities in four states