Agency classClass IIOur severity:High FDA (Devices)·Z-0721-2020·Announced 2020-01-01

Mazor Robotics Recalls Snapshot Tracker Kits Due to Manufacturing Defects

Mazor Robotics is recalling 93 Snapshot Tracker Kits because they were not manufactured to specifications, potentially causing navigational inaccuracies and patient injury.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury (nerve damage/neurological deficit) is a potential consequence of the defect, but the source text does not report that injuries have actually occurred.

Plain-English summary

Mazor Robotics Ltd is recalling 93 Snapshot Tracker Kits (Mas2659-01, KIT0898) because the firm determined that the devices were not manufactured in accordance with specifications. The affected units are prescription-only, non-sterile medical devices with UDI 07290109181868.

The recall is being conducted because the manufacturing defects could potentially lead to navigational inaccuracies during use. These inaccuracies may result in patient injury, including nerve damage or neurological deficit and dysfunction. The FDA has classified this recall as Class II.

The affected products were distributed in 27 U.S. states, including Arizona, California, Florida, New York, and Texas. The specific lot numbers involved are 070494, 070548, 070551, 070481, 070490, 070495, 070542, and 070496. Healthcare providers and facilities should stop using these devices and contact Mazor Robotics for further instructions.

The recalled product

Product: Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Manufacturer: Mazor Robotics Ltd
Category: Medical Device — Surgical Navigation
Hazard: manufacturing-defect
nerve-damage
neurological-deficit
Affected units: 93

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

Lot Numbers: 070494
070548
070551
070481
070490
070495
070542
070496

Distribution

Distributed in 26 states:

Same manufacturer · Mazor Robotics Ltd

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