Zimmer Biomet Recalls ROSA Surgical Device Foot Switches
Zimmer Biomet is recalling 64 ROSA surgical device foot switches that may freeze or shut down during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a malfunction (freezing/shutdown) poses a risk of harm to patients during surgery, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 64 Herga foot switches, model 6289-WS, which are components of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The foot switches are manufactured by Herga Electric Limited. The ROSA device is a computer-controlled electromechanical arm intended for use by neurosurgeons in the operating room to guide standard neurosurgical instruments.
The recall was initiated after complaints were received reporting that the system would freeze or shut down while in Fulgurate mode. This malfunction could potentially interrupt surgical procedures.
The affected devices were distributed nationwide in the United States and internationally to Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and the United Kingdom. Users should contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- 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 switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 64
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- RO10011
- RO10014
- RO13023
- RO13027
- RO14033
- RO14035
- RO14037
- RO14038
- RO14039
- RO14040
- RO14041
- RO14043
- RO15044
- RO15045
- RO15046
- RO15048
- RO15050
- RO15051
- RO15052
- RO15053
Distribution
Distributed nationwide across the United States.
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