CLASS II Device recall · Reported 29 Nov 2017 · FDA Enforcement Report
ROSA Surgical Device 5.8, a computer-controlled recalled
Zimmer Biomet is recalling ROSA Surgical Device 5.8, a computer-controlled electromechanical arm to guide standard, distributed in Arkansas, Georgia, Michigan, Ohio, Texas. The recall was initiated on 6 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0160-2018
- FDA event ID
- 77626
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Nov 2014
- FDA classified
- 20 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 6 Nov 2014 | Recall initiated by company | |
| 20 Nov 2017 | Classified by FDA | +1110 days |
| 29 Nov 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Where it was distributed
US distribution in AR, GA, OH, MI, and TX.
Questions about this recall
Is ROSA Surgical Device 5.8, a computer-controlled electromechanical arm to guide standard recalled?
Yes. Zimmer Biomet recalled ROSA Surgical Device 5.8, a computer-controlled electromechanical arm to guide standard on 6 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0160-2018.
Why was it recalled?
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Which lots are affected?
Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
Where was it sold?
US distribution in AR, GA, OH, MI, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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