Recalls / —
—#156928
Product
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
- FDA product code
- HAW — Neurological Stereotaxic Instrument
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K092239, K101791
- Affected lot / code info
- Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
Why it was 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).
Root cause (FDA determination)
Device Design
Action the firm took
All 9 domestic units were corrected by the firm in February 2017, via technician visits to consignee sites.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 1800 W Center St, Warsaw, Indiana 46580-2304
Distribution
- Distribution pattern
- US distribution in AR, GA, OH, MI, and TX.
Timeline
- Recall initiated
- 2014-11-06
- Terminated
- 2020-07-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #156928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.