Zimmer Biomet Recalls ROSA Surgical Device Due to Navigation Software Shift
Zimmer Biomet is recalling 21 ROSA Surgical Devices because an undetected shift between the navigation software display and actual patient anatomy was identified.
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 is classified as FDA Class II. The hazard involves a potential mismatch between software display and patient anatomy, which poses a risk of harm in a surgical setting, but the source text does not report specific injuries or fatalities.
Plain-English summary
Zimmer Biomet, Inc. is recalling 21 units of the ROSA Surgical Device 2.5.8. This medical device is intended for use in the operating room for the spatial positioning and orientation of an instrument holder or tool guide.
The recall was initiated due to an undetected shift between the information displayed in the navigation software and the actual patient anatomy. The affected units are identified by serial numbers RO10009, RO10011, RO10014, and RO13023.
The devices were distributed to facilities in Ohio, Michigan, and Texas. The recall includes 4 units in the United States and 17 units outside the United States. Healthcare facilities should contact Zimmer Biomet for instructions on how to return the devices.
The recalled product
- Product
- ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
- Manufacturer
- Zimmer Biomet, Inc.
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 (5)
- Serial #s
- RO10009
- RO10011
- RO10014
- and RO13023
Distribution
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