—#154304

Product

MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurological procedure in which the use of stereotactic surgery may be appropriate.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K151359
Affected lot / code info: Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023 and BR16025.

Why it was recalled

Unapproved change made by the supplier.

Root cause (FDA determination)

Component change control

Action the firm took

Zimmer Biomet sent an Urgent Medical Device Recall Correction letter on February 27, 2017,to all affected customers informing them of the following: Description of the issue: A robot arm file parameter linked to arm calibration was modified by the robot arm supplier without notification to MEDTECH. As a result, once the robot arm is on trajectory, an error leading to a device reboot may decrease the devices applicative accuracy, one of the essential performance requirements, to a level above the specification. This may happen after a shutdown of the device, (voluntary or due to an error), without a return of the robot arm position to a Parking position. In the worst case scenario, this may cause an incorrect positioning of the instruments by the ROSA devices. If this is not detected by the user this could ultimately lead to ineffective treatment, serious injury or even death of the patient. MEDTECH did not record, in normal conditions of use, any customer reports linked to this issue. Required actions by users: Pending the implementation of a permanent correction, MEDTECH is recommending the following actions to all users of the ROSA device: 1- After a shutdown of the device, (voluntary or due to an error), without a return of the robot arm in Parking position, ROSA device must be switched off with the I/O switch button on the device rear panel. 2- Restart the device after 10 seconds, and after full extinction of emergency button light. If the Reset button at the device rear panel is red, restart the ROSA PC by pushing the Reset button. 3- If robot position is NOT Home , load patient folder and main software interface will appear on the screen. a. Go to the Guidance menu, select trajectories and follow instructions. b. Click on Start button. c. Start recovery procedure and follow all instructions displayed on the screen until robot arm position is Home. d. Close the patient folder e. Click on Exit and follow all ins

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.

Timeline

Recall initiated: 2017-02-27
Posted by FDA: 2017-03-27
Terminated: 2019-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154304. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.