Recalls / —
—#157799
Product
ROSA Surgical Device 2.5.8
- FDA product code
- HAW — Neurological Stereotaxic Instrument
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K101791
- Affected lot / code info
- Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062
Why it was recalled
Potential for software to change the final tool orientation for the command position without command.
Root cause (FDA determination)
Software design
Action the firm took
Field Service Technicians visited consignee locations to perform system upgrades and have been completed.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 1800 W Center St, Warsaw, Indiana 46580-2304
Distribution
- Distribution pattern
- AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom
Timeline
- Recall initiated
- 2016-04-08
- Terminated
- 2020-07-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #157799. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.