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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81521

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 26, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mazor Robotics Ltd

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0609-2019
Recall number
Z-0609-2019
Initiated
November 26, 2014
Classification
Class II
Status
Terminated
Recalling firm
Mazor Robotics Ltd
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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