Zimmer Biomet Recalls ROSA Surgical Device Due to Software Error
Zimmer Biomet is recalling 64 ROSA Surgical Device 2.5.8 units because a software defect may change tool orientation without user command.
What this means for you
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 functional defect that could affect surgical precision, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 64 units of the ROSA Surgical Device 2.5.8. The recall is due to a potential software defect that could change the final tool orientation for the command position without a user command.
The affected devices were distributed in the United States (AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA) and internationally (Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and the United Kingdom). Specific serial numbers are listed in the official recall notice.
Healthcare providers and consumers should contact Zimmer Biomet for instructions on how to address the software issue. The FDA has classified this as a Class II recall.
The recalled product
- Product
- ROSA Surgical Device 2.5.8
- Manufacturer
- Zimmer Biomet, Inc.
- Category
- Medical Device — Surgical Robot
- 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)
- Serial No. RO15050
- RO15044
- RO15048
- RO15067
- RO15045
- RO15061
- RO14041
- RO14038
- RO14039
- RO14043
- RO15051
- RO15069
- RO10011
- RO14037
- RO10014
- RO15054
- RO14035
- RO15060
- RO15063
- RO14033
Distribution
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