FDA Device

ROSA Surgical Device 2.5.8

Hazard

Potential for software to change the final tool orientation for the command position without command.

What You Should Do

Remedy

Field Service Technicians visited consignee locations to perform system upgrades and have been completed.

Products

ROSA Surgical Device 2.5.8
Brand
Zimmer Biomet, Inc.
UPC
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

Units Affected

64 units