Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0161-2018)

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 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

Product Classification:

Class II

Date Initiated: June 4, 2014

Date Posted: November 29, 2017

Recall Number: Z-0161-2018

Event ID: 77750

Reason for Recall:

Software corrections reactivating the cooperative endoscopy mode.

Status: Terminated

Product Quantity: 29 devices(8 US and 21 OUS)

Code Information:

Serial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020.

Distribution Pattern:

Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated