Agency classClass IIOur severity:High FDA (Devices)·Z-0115-2018·Announced 2017-11-29

Zimmer Biomet Recalls ROSA Surgical Device Due to Software Error

Zimmer Biomet is recalling 64 ROSA Surgical Device 2.5.8 units because a software defect may change tool orientation without user command.

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 medical device with a functional defect that could affect surgical precision, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Zimmer Biomet, Inc. is recalling 64 units of the ROSA Surgical Device 2.5.8. The recall is due to a potential software defect that could change the final tool orientation for the command position without a user command.

The affected devices were distributed in the United States (AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA) and internationally (Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and the United Kingdom). Specific serial numbers are listed in the official recall notice.

Healthcare providers and consumers should contact Zimmer Biomet for instructions on how to address the software issue. The FDA has classified this as a Class II recall.

The recalled product

Product: ROSA Surgical Device 2.5.8
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Surgical Robot
Hazard: software-defect
unintended-movement
Affected units: 64

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. RO15050
RO15044
RO15048
RO15067
RO15045
RO15061
RO14041
RO14038
RO14039
RO14043
RO15051
RO15069
RO10011
RO14037
RO10014
RO15054
RO14035
RO15060
RO15063
RO14033

Distribution

Distributed in 16 states:

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · software defect