Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0184-2018·Announced 2017-12-06

Zimmer Biomet Recalls ROSA Surgical Device Due to Software Issue

Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue in the MXTTOUT controller parameter settings.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is described as a software issue that has been corrected, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 29 units of the ROSA Surgical Device 2.5.8. The device is a computer-controlled electromechanical arm intended for use in the operating room by neurosurgeons to guide standard neurosurgical instruments. The recall involves 8 units in the United States and 21 units outside the United States.

The recall is due to a software issue described in the source text. The issue was corrected in the modification to the MXTTOUT controller parameter settings. The affected devices were distributed nationwide to Alaska, Ohio, Texas, Georgia, and Michigan. Specific serial numbers affected include RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, and RO14035.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any injuries or illnesses associated with the use of these devices.

The recalled product

Product: ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Surgical Robotics
Hazard: software-error

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 (7)

Serial #'s: RO10009
RO10011
RO10014
RO13023
RO13027
RO14031
RO14033 and RO14035

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · software error