—#157265

Product

ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. 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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K092239, K101791
Affected lot / code info: Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15058, RO15059, RO15061, RO15063, RO15064, and RO15069

Why it was recalled

Observed instability of the device.

Root cause (FDA determination)

Device Design

Action the firm took

Zimmer Bioment notified consignees of the recall by visits from Field Service Technicians of the recalling firm looking to correct the device issue. For questions regarding this recall call 574-267-6131.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX

Timeline

Recall initiated: 2013-02-05
Terminated: 2020-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.