Z-1755-2017Class II

MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument...

Name: Z-1755-2017 MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument...
Creator: Zimmer Biomet, Inc.
Published: 2017-02-27
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-02-27 / Terminated / root cause: supplier

FDA source

Zimmer Biomet, Inc. began a recall of MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to... on 2017-02-27. FDA classified it as Class II and gives the reason as "Unapproved change made by the supplier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1755-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-27
Posted: 2017-03-27
Terminated: 2019-08-06
Recalling firm: Zimmer GmbH
Product: MEDTECH ROSA Spine 1.0.2 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 during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Unapproved change made by the supplier.
Root cause tag: supplier
FDA root cause: Component change control
Action: 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
Quantity in commerce: 1
Distribution: Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
Product codes and lots: Serial #'s: SP16008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1755-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1754-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-07
Z-1755-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-07

Product code OLO

K151511Class IIROSA SpineMedtech S.A / cleared 2016-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)