Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0115-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

ROSA Surgical Device 2.5.8

Product Classification:

Class II

Date Initiated: April 8, 2016

Date Posted: November 29, 2017

Recall Number: Z-0115-2018

Event ID: 77743

Reason for Recall:

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

Status: Terminated

Product Quantity: 64 units

Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated