CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report
Carousel MAS1025-01, part of the Brain Surgical Accessories recalled
Mazor Robotics is recalling Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295). The recall was initiated on 26 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0609-2019
- FDA event ID
- 81521
- Recalling firm
- Mazor Robotics, North Industrial Park
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Nov 2014
- FDA classified
- 14 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 26 Nov 2014 | Recall initiated by company | |
| 14 Dec 2018 | Classified by FDA | +1479 days |
| 26 Dec 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Product as listed by the FDA
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.
Where it was distributed
Affected devices were distributed in the US to four different medical facilities in four states
Questions about this recall
Why was it 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.
Which lots 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).
Where was it sold?
Affected devices were distributed in the US to four different medical facilities in four states
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mazor Robotics
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Mazor X robotic guidance system recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Mazor recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Mazor X robotic guidance system recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Snapshot Tracker Kit, Mas2659-01, KIT0898 recalled by Mazor Robotics | Mazor Robotics | Other | 26 states |
Other Spinal Implants recalls
All 1,159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |