Zimmer Biomet Recalls ROSA Surgical Device 2.5.8 Units
Zimmer Biomet is recalling 22 ROSA Surgical Device 2.5.8 units due to an issue with the optional neuro-endoscopy module detected during internal testing.
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 and involves a surgical device where a functional issue was detected during testing, but no injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 22 units of the ROSA Surgical Device 2.5.8. The recall involves 4 units in the United States and 18 units outside the US. The affected units have serial numbers RO10011, RO10014, RO13023, and RO13027.
The recall was initiated because an issue with the optional neuro-endoscopy module was detected under specific conditions during internal testing. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected devices were distributed to facilities in Arkansas, Ohio, Michigan, and Texas. Healthcare providers and facilities that have received these specific serial numbers should stop using the affected units and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- ROSA Surgical Device 2.5.8
- Manufacturer
- Zimmer Biomet, Inc.
- Category
- Medical Device — Surgical Robot
- Hazard
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 (3)
- Serial No. RO10011
- RO10014
- RO13023 and RO13027
Distribution
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