Recalls / —
—#159361
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
- FDA product code
- HAW — Neurological Stereotaxic Instrument
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K092239, K101791
- Affected lot / code info
- Serial #s; RO10009, RO10011, RO10014, and RO13023
Why it was recalled
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Root cause (FDA determination)
Error in labeling
Action the firm took
There were 4 units imported into the US and all have been corrected.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 1800 W Center St, Warsaw, Indiana 46580-2304
Distribution
- Distribution pattern
- OH, MI and TX
Timeline
- Recall initiated
- 2014-02-14
- Terminated
- 2020-09-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #159361. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.