Agency classClass IIOur severity:High FDA (Devices)·Z-0099-2018·Announced 2017-11-22

Zimmer Biomet Recalls ROSA Surgical Devices Due to Observed Instability

Zimmer Biomet is recalling 53 ROSA Surgical Devices because of observed instability. The devices are computer-controlled arms used in neurosurgery.

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 is classified as FDA Class II. The hazard is 'observed instability' of a surgical device, which poses a risk of harm during surgery, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Biomet, Inc. is recalling 53 units of the ROSA Surgical Device 2.5.8. This device is a computer-controlled electromechanical arm intended for use in the operating room to guide standard neurosurgical instruments. The recall is being conducted due to observed instability of the device.

The affected units were distributed nationwide to hospitals in Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Michigan, New York, Ohio, Pennsylvania, and Texas. The recall includes specific serial numbers ranging from RO10009 to RO15069.

Healthcare facilities should stop using the affected devices and contact Zimmer Biomet for instructions on how to proceed. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the device could cause temporary or medically reversible adverse health consequences.

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…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Surgical Robot
Hazard: device-instability
Affected units: 53

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 (20)

Serial No. RO10009
RO10011
RO10014
RO13023
RO13027
RO14031
RO14033
RO14035
RO14037
RO14038
RO14039
RO14040
RO14041
RO14043
RO15044
RO15045
RO15046
RO15048
RO15050
RO15051

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · device instability