Herga foot switch recall
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…
Why was Herga foot switch recalled?
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers for ROSA devices with the Herga Footswitch in US distribution: Serial 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. RO08003, RO09004, RO09005, RO10007, RO10010, RO10013, RO11015, RO11016, RO11017, RO12018, RO12019, RO12020, RO12021, RO12022, RO13024, RO13025, RO13026, RO14029, RO14030, RO14032, RO14034, RO14036, RO14042, RO15047, RO15049, RO15055, RO15056, RO15057, RO15065, RO15066, RO15068, and RO15070.
- Product
- 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…
- Recalling firm
- Zimmer Biomet, Inc.
- 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.
- Recall date
- September 20, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)