Carousel MAS1025-01 — Class II medical device recall Z-0609-2019
Terminated recall by Mazor Robotics Ltd, reported 2018-12-26. In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the ca
| Recall number | Z-0609-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mazor Robotics Ltd, North Industrial Park, Israel |
| Recall initiated | 2014-11-26 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2019-07-03 |
| Quantity | 5 units |
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 to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0609-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.