Zimmer Biomet ROSA Surgical Device Recalled for Potential Force Sensor Break
Zimmer Biomet is recalling 21 ROSA Surgical Devices due to a possible break in the Force Sensor connector. The devices were distributed to facilities in Ohio, Michigan, and Texas.
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 medical device with a potential mechanical defect (broken sensor connector) that could impact surgical guidance. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 21 units of the ROSA Surgical Device 2.5.8. This computer-controlled electromechanical arm is intended for use in the operating room by neurosurgeons to guide standard neurosurgical instruments. The recall is due to a possible break in the connector of the Force Sensor.
The affected devices were distributed nationwide to facilities in Ohio, Michigan, and Texas. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Consumers and healthcare facilities should stop using the affected devices and contact Zimmer Biomet for further instructions on the recall.
The recalled product
- Product
- ROSA Surgical Device 2.5.8 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…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 21
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 (1)
- Model Number: ROSA 2.5.8
Distribution
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