Recall Z-3117-2017 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
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 instrum
| Date | Jan 20, 2016 |
| Status | Terminated |
| Reason | Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. |
| Root cause | Software design |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall Correction letter dated July 26, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product. for all surgical procedures, notify and ensure affected personnel are aware of the contents, complete the attached Certificated of Acknowledgement and return a digital copy. Customers with questions were instructed to call +33 (0) 467 107740, US customers should call 800-874-7711, ext 9225 .The initial correction wa |
| Quantity | 64 devices |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain and the United Kingdom. |
| FDA record | Open on fda.gov |