ROBOT ROSA ONE (USA) recallZ-1151-2020 · Medtech Sas · initiated Jan 6, 2020

Why it was recalled

Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.

FDA root cause category: Software design

What the company is doing

On January 6, 2020, Zimmer Biomet issued URGENT MEDICAL DEVICE CORRECTION notices to customers via FedEx. Actions Required By Users: Your device can continue to be used, as long as the recommendations below are followed: While the current Instructions For Use do not require the images to be reviewed with ROSA Brain software prior to surgery, they adequately describe the standard workflow and indicate that the image acquisition of the patients head (MRI / CT or 2D X-Ray images) is performed prior to surgery, and is then loaded into the device and used by the surgeon in the preoperative phase to carry out the surgical planning. Due to this potential image management issue, Zimmer Biomet recommends that images be reviewed using the ROSA Brain software prior to surgery. If an issue is detected with the reconstruction and display of the images using the ROSA software, and if the artifacts are located in the Region Of Interest and prevent the surgical planning, then the surgery might have to be cancelled or converted to traditional surgery. However, if the artifacts are not located inside the Region Of Interest and if the surgery planning is successful, the affected device can continue to be used. Transmission of the Medical Device Correction: Please advise the appropriate personnel working in your department with the ROSA system of the content of the letter. Risk Manager Responsibilities: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Complete the Certificate of Acknowledgement. a. Return a digital copy to [email protected]. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 3. If you have further questions or concerns after reviewing the notice, please call Perry Twyford at 281-389-3236 between 9:00 am and 6:00pm EST, Monday through Friday. Alternatively, your questions may be e

Recall details

Recall number

Z-1151-2020

Status

Terminated

Initiated by the company

Jan 6, 2020

Recalling firm

Medtech Sas

Quantity

39 units

Product code

HAW

FDA submissions

K151359, K172444, K182417

Distribution

US Nationwide

Product description

ROSA One 3.1 Brain Application

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• ROBOT ROSA ONE (USA) 3.1.1.0

  Medtech · Orthopedic Stereotaxic Instrument
  1 recall22 reports
• ROSA One 3.1.0.5

  Medtech · Neurological Stereotaxic Instrument
  1 recall2 reports

Product lines

• ROBOT ROSA ONE (USA)Medtech · 3 models · 27 reports · 1 recall

Other devices under the same FDA submission

1 device cleared under K151359, K172444, K182417 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• MAYFIELD HEAD HOLDER ADAPTOR ROSA3-177D

  Medtech · Neurological Stereotaxic Instrument
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 84642).

• Z-1150-2020 · Terminated
  ROSA Brain 3.0 Application-Brain