Reported Sep 20, 2017 · Terminated
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. 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 developed with three-dimensional imaging software and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
- Lot codes and dates
- Serial numbers for ROSA devices with
- the Herga Footswitch in US distributionSerial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15052, RO15053, RO15054, RO15058, RO15059, RO15060, RO15061, RO15062, RO15063, RO15064, RO15067, RO15069, and RO14031. Serial numbers for ROSA devices with the Herga
- Footswitch in foreign distribution
Serial No. RO08003RO09004RO09005RO10007RO10010RO10013RO11015RO11016RO11017RO12018RO12019RO12020RO12021RO12022RO13024RO13025RO13026RO14029RO14030RO14032RO14034RO14036RO14042RO15047RO15049RO15055RO15056RO15057RO15065RO15066RO15068and RO15070
- Amount recalled
- 64 devices
Where it was sold
- Nationwide
Why it was recalled
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
This product could cause temporary or reversible health problems — stop using it.
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